{ "openapi": "3.0.3", "info": { "title": "US FDA Recalls & Safety Monitor (Food, Drug & Devices)", "version": "3.0.0", "description": "Monitors and enriches official U.S. FDA enforcement recall reports across Food, Drugs, and Medical Devices via openFDA. Calculates hazard severity scores (0-100) and generates Markdown legal briefs for Product Liability law firms and retail compliance.\n\n### Enterprise B2B Value Proposition (US FDA Recalls & Safety Monitor (Food, Drug & Devices))\n- **Target B2B Buyers:** Pharmaceutical Compliance Teams, Hospital Pharmacies, Retail Supply Chains, and InsurTech Underwriters.\n- **Zero External API Keys Required:** Connects directly to authoritative government, regulatory, and financial primary registries with built-in retry/backoff and deterministic schema normalization.\n- **Quantitative Scoring & RAG Briefs:** Every record is enriched with a quantitative 0-100 risk/viability score and an LLM-ready Markdown executive brief (`US FDA Enforcement Recall Extracted`).\n- **Backend Proxy Secret Injection:** RapidAPI Studio and Zyla API Hub inject `Authorization: Bearer ` invisibly at the proxy layer when forwarding synchronous calls to `https://api.apify.com/v2/acts/b2b-quant-apis~us-fda-recalls-safety-monitor/run-sync-get-dataset-items`.\n- **Marketplace Categories:** RapidAPI `Medical` | Zyla API Hub `Healthcare`.\n- **Subscription Tiers (USD):** `BASIC` ($0.00/mo, 15 req/mo hard cap), `PRO` ($19.00/mo, 1,000 req/mo + $0.02/extra), `ULTRA` ($49.00/mo, 5,000 req/mo + $0.015/extra), `MEGA` ($149.00/mo, 25,000 req/mo + $0.010/extra).\n- **SEO Keywords:** fda-recalls, openfda, drug-safety, medical-device-recalls, food-safety, supply-chain-risk, pharmacovigilance.", "termsOfService": "https://jesleytassili-glitch.github.io/b2b-quant-mcp-n8n-suite/", "contact": { "name": "B2B Quant APIs (@b2b-quant-apis)", "email": "jesleytassili@gmail.com", "url": "https://apify.com/b2b-quant-apis/us-fda-recalls-safety-monitor" }, "license": { "name": "Commercial B2B API Subscription (RapidAPI & Zyla Hub)", "url": "https://apify.com/b2b-quant-apis/us-fda-recalls-safety-monitor" }, "x-category": "Medical", "x-rapidapi-category": "Medical", "x-zyla-category": "Healthcare", "x-seo-tags": [ "fda-recalls", "openfda", "drug-safety", "medical-device-recalls", "food-safety", "supply-chain-risk", "pharmacovigilance" ], "x-payout-destination": "Wise #890361113", "x-pricing-plans": { "BASIC": { "tier": "BASIC", "label": "Freemium Developer Trial", "monthlyPriceUsd": 0.0, "monthlyQuotaRequests": 15, "overagePricePerRequestUsd": 0.0, "hardLimit": true }, "PRO": { "tier": "PRO", "label": "Startup & RevOps Pipeline", "monthlyPriceUsd": 19.0, "monthlyQuotaRequests": 1000, "overagePricePerRequestUsd": 0.02, "hardLimit": false }, "ULTRA": { "tier": "ULTRA", "label": "Mid-Market Automation Cluster", "monthlyPriceUsd": 49.0, "monthlyQuotaRequests": 5000, "overagePricePerRequestUsd": 0.015, "hardLimit": false }, "MEGA": { "tier": "MEGA", "label": "Enterprise High-Throughput SLA", "monthlyPriceUsd": 149.0, "monthlyQuotaRequests": 25000, "overagePricePerRequestUsd": 0.01, "hardLimit": false } }, "x-code-snippets": { "cURL": "# Primary Synchronous Endpoint: https://us-fda-recalls-safety-monitor.p.rapidapi.com/v2/acts/b2b-quant-apis~us-fda-recalls-safety-monitor/run-sync-get-dataset-items (Gateway Route: https://b2b-quant-rapidapi-gateway.jesleytassili.workers.dev/v1/us-fda-recalls-safety-monitor)\ncurl --request POST \\\n --url \"https://us-fda-recalls-safety-monitor.p.rapidapi.com/v2/acts/b2b-quant-apis~us-fda-recalls-safety-monitor/run-sync-get-dataset-items\" \\\n --header \"Content-Type: application/json\" \\\n --header \"X-RapidAPI-Host: us-fda-recalls-safety-monitor.p.rapidapi.com\" \\\n --header \"X-RapidAPI-Key: \" \\\n --data '{\"domain\": \"drug\", \"classification\": \"ALL\", \"keyword\": \"semaglutide\", \"state\": \"\", \"maxResults\": 10}'", "Python": "import httpx\n\n# Primary Synchronous Endpoint (Gateway Route: https://b2b-quant-rapidapi-gateway.jesleytassili.workers.dev/v1/us-fda-recalls-safety-monitor)\nurl = \"https://us-fda-recalls-safety-monitor.p.rapidapi.com/v2/acts/b2b-quant-apis~us-fda-recalls-safety-monitor/run-sync-get-dataset-items\"\npayload = {\n \"domain\": \"drug\",\n \"classification\": \"ALL\",\n \"keyword\": \"semaglutide\",\n \"state\": \"\",\n \"maxResults\": 10\n}\nheaders = {\n \"Content-Type\": \"application/json\",\n \"X-RapidAPI-Host\": \"us-fda-recalls-safety-monitor.p.rapidapi.com\",\n \"X-RapidAPI-Key\": \"\",\n}\n\nwith httpx.Client(timeout=30.0) as client:\n response = client.post(url, json=payload, headers=headers)\n response.raise_for_status()\n print(response.json())\n", "Node.js": "// Primary Synchronous Endpoint (Gateway Route: https://b2b-quant-rapidapi-gateway.jesleytassili.workers.dev/v1/us-fda-recalls-safety-monitor)\nconst url = \"https://us-fda-recalls-safety-monitor.p.rapidapi.com/v2/acts/b2b-quant-apis~us-fda-recalls-safety-monitor/run-sync-get-dataset-items\";\nconst options = {\n method: \"POST\",\n headers: {\n \"Content-Type\": \"application/json\",\n \"X-RapidAPI-Host\": \"us-fda-recalls-safety-monitor.p.rapidapi.com\",\n \"X-RapidAPI-Key\": \"\"\n },\n body: JSON.stringify({\"domain\": \"drug\", \"classification\": \"ALL\", \"keyword\": \"semaglutide\", \"state\": \"\", \"maxResults\": 10})\n};\n\nconst response = await fetch(url, options);\nconst data = await response.json();\nconsole.log(data);\n" }, "x-primary-backend-url": "https://api.apify.com", "x-primary-backend-base-url": "https://api.apify.com", "x-apify-sync-endpoint": "https://api.apify.com/v2/acts/b2b-quant-apis~us-fda-recalls-safety-monitor/run-sync-get-dataset-items", "x-apify-health-endpoint": "https://api.apify.com/v2/acts/b2b-quant-apis~us-fda-recalls-safety-monitor", "x-backend-secret-header": { "name": "Authorization", "valueTemplate": "Bearer ", "headerName": "Authorization", "headerValueTemplate": "Bearer ", "injectedByProxy": true, "hiddenFromSubscriber": true, "description": "Secret Header injected invisibly by RapidAPI Studio and Zyla API Hub proxy when calling https://api.apify.com." }, "x-openapi-spec-url": "https://jesleytassili-glitch.github.io/specs_openapi_31/us-fda-recalls-safety-monitor.json", "x-openapi-suite-spec-url": "https://jesleytassili-glitch.github.io/b2b-quant-mcp-n8n-suite/specs_openapi_31/us-fda-recalls-safety-monitor.json", "x-apis-json-url": "https://jesleytassili-glitch.github.io/apis.json", "x-github-release-tag": "v2.2.0" }, "externalDocs": { "description": "Official B2B Documentation & Schema Reference for US FDA Recalls & Safety Monitor (Food, Drug & Devices)", "url": "https://jesleytassili-glitch.github.io/b2b-quant-mcp-n8n-suite/actors/us-fda-recalls-safety-monitor.html" }, "servers": [ { "url": "https://api.apify.com", "description": "Primary Apify Cloud Synchronous Execution Cluster (Real HTTP 200/201 POST & GET)" }, { "url": "https://api.apify.com/v2/acts/b2b-quant-apis~us-fda-recalls-safety-monitor/run-sync-get-dataset-items", "description": "Direct Apify Actor Synchronous Execution Endpoint (us-fda-recalls-safety-monitor)" }, { "url": "https://b2b-quant-rapidapi-gateway.jesleytassili.workers.dev", "description": "Anti-Bypass Stateless B2B Gateway (RapidAPI & Zyla Hub Proxy)" } ], "tags": [ { "name": "Medical", "description": "RapidAPI Hub primary category: Medical (Zyla Hub: Healthcare)" }, { "name": "fda-recalls", "description": "B2B SEO Search Tag: fda-recalls" }, { "name": "openfda", "description": "B2B SEO Search Tag: openfda" }, { "name": "drug-safety", "description": "B2B SEO Search Tag: drug-safety" }, { "name": "medical-device-recalls", "description": "B2B SEO Search Tag: medical-device-recalls" }, { "name": "food-safety", "description": "B2B SEO Search Tag: food-safety" }, { "name": "supply-chain-risk", "description": "B2B SEO Search Tag: supply-chain-risk" }, { "name": "pharmacovigilance", "description": "B2B SEO Search Tag: pharmacovigilance" } ], "security": [ { "ApifyCloudBearerAuth": [] }, { "RapidAPIProxySecret": [] }, { "ZylaProxySecret": [] }, { "RapidAPISubscriberKey": [] } ], "paths": { "/v2/acts/b2b-quant-apis~us-fda-recalls-safety-monitor/run-sync-get-dataset-items": { "post": { "operationId": "run_sync_us_fda_recalls_safety_monitor", "summary": "Execute US FDA Recalls & Safety Monitor (Food, Drug & Devices) (Apify Cloud Synchronous POST)", "description": "Synchronous stateless execution of **US FDA Recalls & Safety Monitor (Food, Drug & Devices)**. RapidAPI Studio and Zyla API Hub inject the backend secret header `Authorization: Bearer ` invisibly to the end user, validate `X-RapidAPI-Proxy-Secret` / `X-Zyla-Proxy-Secret` in constant time (`hmac.compare_digest`), inject quota headers (`X-RateLimit-Remaining`, `X-Engine-Version`), and return deterministic JSON records.", "tags": [ "Medical", "fda-recalls", "openfda", "drug-safety", "medical-device-recalls", "food-safety" ], "x-codeSamples": [ { "lang": "cURL", "label": "cURL", "source": "# Primary Synchronous Endpoint: https://us-fda-recalls-safety-monitor.p.rapidapi.com/v2/acts/b2b-quant-apis~us-fda-recalls-safety-monitor/run-sync-get-dataset-items (Gateway Route: https://b2b-quant-rapidapi-gateway.jesleytassili.workers.dev/v1/us-fda-recalls-safety-monitor)\ncurl --request POST \\\n --url \"https://us-fda-recalls-safety-monitor.p.rapidapi.com/v2/acts/b2b-quant-apis~us-fda-recalls-safety-monitor/run-sync-get-dataset-items\" \\\n --header \"Content-Type: application/json\" \\\n --header \"X-RapidAPI-Host: us-fda-recalls-safety-monitor.p.rapidapi.com\" \\\n --header \"X-RapidAPI-Key: \" \\\n --data '{\"domain\": \"drug\", \"classification\": \"ALL\", \"keyword\": \"semaglutide\", \"state\": \"\", \"maxResults\": 10}'" }, { "lang": "Python", "label": "Python (httpx)", "source": "import httpx\n\n# Primary Synchronous Endpoint (Gateway Route: https://b2b-quant-rapidapi-gateway.jesleytassili.workers.dev/v1/us-fda-recalls-safety-monitor)\nurl = \"https://us-fda-recalls-safety-monitor.p.rapidapi.com/v2/acts/b2b-quant-apis~us-fda-recalls-safety-monitor/run-sync-get-dataset-items\"\npayload = {\n \"domain\": \"drug\",\n \"classification\": \"ALL\",\n \"keyword\": \"semaglutide\",\n \"state\": \"\",\n \"maxResults\": 10\n}\nheaders = {\n \"Content-Type\": \"application/json\",\n \"X-RapidAPI-Host\": \"us-fda-recalls-safety-monitor.p.rapidapi.com\",\n \"X-RapidAPI-Key\": \"\",\n}\n\nwith httpx.Client(timeout=30.0) as client:\n response = client.post(url, json=payload, headers=headers)\n response.raise_for_status()\n print(response.json())\n" }, { "lang": "Node.js", "label": "Node.js (fetch)", "source": "// Primary Synchronous Endpoint (Gateway Route: https://b2b-quant-rapidapi-gateway.jesleytassili.workers.dev/v1/us-fda-recalls-safety-monitor)\nconst url = \"https://us-fda-recalls-safety-monitor.p.rapidapi.com/v2/acts/b2b-quant-apis~us-fda-recalls-safety-monitor/run-sync-get-dataset-items\";\nconst options = {\n method: \"POST\",\n headers: {\n \"Content-Type\": \"application/json\",\n \"X-RapidAPI-Host\": \"us-fda-recalls-safety-monitor.p.rapidapi.com\",\n \"X-RapidAPI-Key\": \"\"\n },\n body: JSON.stringify({\"domain\": \"drug\", \"classification\": \"ALL\", \"keyword\": \"semaglutide\", \"state\": \"\", \"maxResults\": 10})\n};\n\nconst response = await fetch(url, options);\nconst data = await response.json();\nconsole.log(data);\n" } ], "x-snippets": { "cURL": "# Primary Synchronous Endpoint: https://us-fda-recalls-safety-monitor.p.rapidapi.com/v2/acts/b2b-quant-apis~us-fda-recalls-safety-monitor/run-sync-get-dataset-items (Gateway Route: https://b2b-quant-rapidapi-gateway.jesleytassili.workers.dev/v1/us-fda-recalls-safety-monitor)\ncurl --request POST \\\n --url \"https://us-fda-recalls-safety-monitor.p.rapidapi.com/v2/acts/b2b-quant-apis~us-fda-recalls-safety-monitor/run-sync-get-dataset-items\" \\\n --header \"Content-Type: application/json\" \\\n --header \"X-RapidAPI-Host: us-fda-recalls-safety-monitor.p.rapidapi.com\" \\\n --header \"X-RapidAPI-Key: \" \\\n --data '{\"domain\": \"drug\", \"classification\": \"ALL\", \"keyword\": \"semaglutide\", \"state\": \"\", \"maxResults\": 10}'", "Python": "import httpx\n\n# Primary Synchronous Endpoint (Gateway Route: https://b2b-quant-rapidapi-gateway.jesleytassili.workers.dev/v1/us-fda-recalls-safety-monitor)\nurl = \"https://us-fda-recalls-safety-monitor.p.rapidapi.com/v2/acts/b2b-quant-apis~us-fda-recalls-safety-monitor/run-sync-get-dataset-items\"\npayload = {\n \"domain\": \"drug\",\n \"classification\": \"ALL\",\n \"keyword\": \"semaglutide\",\n \"state\": \"\",\n \"maxResults\": 10\n}\nheaders = {\n \"Content-Type\": \"application/json\",\n \"X-RapidAPI-Host\": \"us-fda-recalls-safety-monitor.p.rapidapi.com\",\n \"X-RapidAPI-Key\": \"\",\n}\n\nwith httpx.Client(timeout=30.0) as client:\n response = client.post(url, json=payload, headers=headers)\n response.raise_for_status()\n print(response.json())\n", "Node.js": "// Primary Synchronous Endpoint (Gateway Route: https://b2b-quant-rapidapi-gateway.jesleytassili.workers.dev/v1/us-fda-recalls-safety-monitor)\nconst url = \"https://us-fda-recalls-safety-monitor.p.rapidapi.com/v2/acts/b2b-quant-apis~us-fda-recalls-safety-monitor/run-sync-get-dataset-items\";\nconst options = {\n method: \"POST\",\n headers: {\n \"Content-Type\": \"application/json\",\n \"X-RapidAPI-Host\": \"us-fda-recalls-safety-monitor.p.rapidapi.com\",\n \"X-RapidAPI-Key\": \"\"\n },\n body: JSON.stringify({\"domain\": \"drug\", \"classification\": \"ALL\", \"keyword\": \"semaglutide\", \"state\": \"\", \"maxResults\": 10})\n};\n\nconst response = await fetch(url, options);\nconst data = await response.json();\nconsole.log(data);\n" }, "x-backend-secret-header": { "name": "Authorization", "value": "Bearer ", "visibleToSubscriber": false }, "requestBody": { "required": true, "description": "Structured JSON parameters for `us-fda-recalls-safety-monitor`.", "content": { "application/json": { "schema": { "$ref": "#/components/schemas/UsFdaRecallsSafetyMonitorRequest" }, "example": { "domain": "drug", "classification": "ALL", "keyword": "semaglutide", "state": "", "maxResults": 10 } } } }, "responses": { "200": { "description": "Successful synchronous execution of `us-fda-recalls-safety-monitor` returning enriched B2B JSON records.", "headers": { "X-RateLimit-Remaining": { "description": "Remaining requests in the subscriber's monthly plan quota (BASIC=15, PRO=1000, ULTRA=5000, MEGA=25000).", "schema": { "type": "integer", "example": 999 } }, "X-Engine-Version": { "description": "Deterministic B2B engine release version.", "schema": { "type": "string", "example": "3.0.0" } } }, "content": { "application/json": { "schema": { "$ref": "#/components/schemas/UsFdaRecallsSafetyMonitorResponseEnvelope" }, "example": { "status": "succeeded", "actor": "us-fda-recalls-safety-monitor", "engineVersion": "3.0.0", "count": 1, "data": [ { "recallNumber": "D-0026-2027", "eventId": "99867", "domain": "drug", "classification": "Class II", "severityScore": 75, "recallingFirm": "Carolina Infusion, LLC", "city": "Ridgeland", "state": "SC", "country": "United States", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "reportDate": "2026-10-14", "recallInitiationDate": "2026-09-10", "centerClassificationDate": "2026-10-08", "reasonForRecall": "Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.", "productDescription": "SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936", "productQuantity": "82.9 mls - in patient specific syringe dose", "codeInfo": "Lot: 07242026@1, BUD: 9/7/2026; 08032026@20, BUD: 9/17/2026; 08312026@16, BUD: 10/15/2026; 08242026@28, BUD: 10/8/2026; 08072026@16, BUD: 9/21/2026. .", "distributionPattern": "Nationwide within the U.S", "markdownLegalBrief": "# FDA ENFORCEMENT & PRODUCT LIABILITY BRIEF: D-0026-2027\n\n## 1. Executive Risk Summary\n- **Regulatory Domain:** FDA DRUG\n- **Hazard Classification:** Class II (MODERATE / REVERSIBLE HAZARD)\n- **Quantitative Severity Score:** 75/100\n- **Enforcement Status:** Ongoing\n- **Report Date:** 2026-10-14 (Initiated: 2026-09-10)\n\n## 2. Recalling Entity & Jurisdiction\n- **Recalling Firm:** Carolina Infusion, LLC\n- **Location:** Ridgeland, SC (United States)\n- **Action Type:** Voluntary: Firm initiated\n- **Distribution Scope:** Nationwide within the U.S\n\n## 3. Defect & Hazard Analysis\n- **Reason for Recall:** Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.\n- **Affected Product Description:** SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on..." } ] } } } }, "201": { "description": "Synchronous dataset created and returned for `us-fda-recalls-safety-monitor` on Apify Cloud (`HTTP 201`).", "content": { "application/json": { "schema": { "$ref": "#/components/schemas/UsFdaRecallsSafetyMonitorResponseEnvelope" }, "example": { "status": "succeeded", "actor": "us-fda-recalls-safety-monitor", "engineVersion": "3.0.0", "count": 1, "data": [ { "recallNumber": "D-0026-2027", "eventId": "99867", "domain": "drug", "classification": "Class II", "severityScore": 75, "recallingFirm": "Carolina Infusion, LLC", "city": "Ridgeland", "state": "SC", "country": "United States", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "reportDate": "2026-10-14", "recallInitiationDate": "2026-09-10", "centerClassificationDate": "2026-10-08", "reasonForRecall": "Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.", "productDescription": "SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936", "productQuantity": "82.9 mls - in patient specific syringe dose", "codeInfo": "Lot: 07242026@1, BUD: 9/7/2026; 08032026@20, BUD: 9/17/2026; 08312026@16, BUD: 10/15/2026; 08242026@28, BUD: 10/8/2026; 08072026@16, BUD: 9/21/2026. .", "distributionPattern": "Nationwide within the U.S", "markdownLegalBrief": "# FDA ENFORCEMENT & PRODUCT LIABILITY BRIEF: D-0026-2027\n\n## 1. Executive Risk Summary\n- **Regulatory Domain:** FDA DRUG\n- **Hazard Classification:** Class II (MODERATE / REVERSIBLE HAZARD)\n- **Quantitative Severity Score:** 75/100\n- **Enforcement Status:** Ongoing\n- **Report Date:** 2026-10-14 (Initiated: 2026-09-10)\n\n## 2. Recalling Entity & Jurisdiction\n- **Recalling Firm:** Carolina Infusion, LLC\n- **Location:** Ridgeland, SC (United States)\n- **Action Type:** Voluntary: Firm initiated\n- **Distribution Scope:** Nationwide within the U.S\n\n## 3. Defect & Hazard Analysis\n- **Reason for Recall:** Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.\n- **Affected Product Description:** SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on..." } ] } } } }, "400": { "description": "Bad Request — Invalid JSON payload or schema validation error.", "content": { "application/json": { "schema": { "$ref": "#/components/schemas/ErrorResponse" }, "example": { "status": "error", "code": 400, "message": "Invalid JSON request body." } } } }, "403": { "description": "Forbidden — Missing or invalid `X-RapidAPI-Proxy-Secret` / `X-Zyla-Proxy-Secret` header (Anti-Bypass Protection).", "content": { "application/json": { "schema": { "$ref": "#/components/schemas/ErrorResponse" }, "example": { "status": "forbidden", "code": 403, "message": "Direct access denied. Requests must originate from RapidAPI Hub or Zyla API Hub with a valid Proxy-Secret." } } } }, "429": { "description": "Too Many Requests — Monthly plan quota exceeded (e.g., BASIC Freemium 15 req/month hard limit).", "content": { "application/json": { "schema": { "$ref": "#/components/schemas/ErrorResponse" }, "example": { "status": "quota_exceeded", "code": 429, "message": "Monthly request quota exceeded for BASIC plan (15 req/month hard limit). Upgrade to PRO ($19/mo), ULTRA ($49/mo), or MEGA ($149/mo)." } } } } } } }, "/v2/acts/b2b-quant-apis~us-fda-recalls-safety-monitor": { "get": { "operationId": "status_us_fda_recalls_safety_monitor", "summary": "Actor Metadata & Live Connectivity Check for US FDA Recalls & Safety Monitor (Food, Drug & Devices)", "description": "Immediate `HTTP 200` status and metadata health check for `us-fda-recalls-safety-monitor` on RapidAPI Studio and Zyla API Hub (`GET https://api.apify.com/v2/acts/b2b-quant-apis~us-fda-recalls-safety-monitor` and `GET /v1/us-fda-recalls-safety-monitor/health`) without starting a container build or run.", "tags": [ "Medical" ], "responses": { "200": { "description": "Engine online and ready (`HTTP 200 JSON`).", "content": { "application/json": { "schema": { "type": "object", "properties": { "status": { "type": "string", "example": "ok" }, "actor": { "type": "string", "example": "us-fda-recalls-safety-monitor" }, "engineVersion": { "type": "string", "example": "3.0.0" }, "category": { "type": "string", "example": "Medical" }, "data": { "type": "object", "additionalProperties": true, "example": { "name": "us-fda-recalls-safety-monitor", "username": "b2b-quant-apis", "isPublic": true } } } }, "example": { "status": "ok", "actor": "us-fda-recalls-safety-monitor", "engineVersion": "3.0.0", "category": "Medical", "data": { "name": "us-fda-recalls-safety-monitor", "username": "b2b-quant-apis", "isPublic": true } } } } } } } }, "/v1/us-fda-recalls-safety-monitor": { "post": { "operationId": "execute_us_fda_recalls_safety_monitor", "summary": "Execute US FDA Recalls & Safety Monitor (Food, Drug & Devices)", "description": "Synchronous stateless execution of **US FDA Recalls & Safety Monitor (Food, Drug & Devices)**. RapidAPI Studio and Zyla API Hub inject the backend secret header `Authorization: Bearer ` invisibly to the end user, validate `X-RapidAPI-Proxy-Secret` / `X-Zyla-Proxy-Secret` in constant time (`hmac.compare_digest`), inject quota headers (`X-RateLimit-Remaining`, `X-Engine-Version`), and return deterministic JSON records.", "tags": [ "Medical", "fda-recalls", "openfda", "drug-safety", "medical-device-recalls", "food-safety" ], "x-codeSamples": [ { "lang": "cURL", "label": "cURL", "source": "# Primary Synchronous Endpoint: https://us-fda-recalls-safety-monitor.p.rapidapi.com/v2/acts/b2b-quant-apis~us-fda-recalls-safety-monitor/run-sync-get-dataset-items (Gateway Route: https://b2b-quant-rapidapi-gateway.jesleytassili.workers.dev/v1/us-fda-recalls-safety-monitor)\ncurl --request POST \\\n --url \"https://us-fda-recalls-safety-monitor.p.rapidapi.com/v2/acts/b2b-quant-apis~us-fda-recalls-safety-monitor/run-sync-get-dataset-items\" \\\n --header \"Content-Type: application/json\" \\\n --header \"X-RapidAPI-Host: us-fda-recalls-safety-monitor.p.rapidapi.com\" \\\n --header \"X-RapidAPI-Key: \" \\\n --data '{\"domain\": \"drug\", \"classification\": \"ALL\", \"keyword\": \"semaglutide\", \"state\": \"\", \"maxResults\": 10}'" }, { "lang": "Python", "label": "Python (httpx)", "source": "import httpx\n\n# Primary Synchronous Endpoint (Gateway Route: https://b2b-quant-rapidapi-gateway.jesleytassili.workers.dev/v1/us-fda-recalls-safety-monitor)\nurl = \"https://us-fda-recalls-safety-monitor.p.rapidapi.com/v2/acts/b2b-quant-apis~us-fda-recalls-safety-monitor/run-sync-get-dataset-items\"\npayload = {\n \"domain\": \"drug\",\n \"classification\": \"ALL\",\n \"keyword\": \"semaglutide\",\n \"state\": \"\",\n \"maxResults\": 10\n}\nheaders = {\n \"Content-Type\": \"application/json\",\n \"X-RapidAPI-Host\": \"us-fda-recalls-safety-monitor.p.rapidapi.com\",\n \"X-RapidAPI-Key\": \"\",\n}\n\nwith httpx.Client(timeout=30.0) as client:\n response = client.post(url, json=payload, headers=headers)\n response.raise_for_status()\n print(response.json())\n" }, { "lang": "Node.js", "label": "Node.js (fetch)", "source": "// Primary Synchronous Endpoint (Gateway Route: https://b2b-quant-rapidapi-gateway.jesleytassili.workers.dev/v1/us-fda-recalls-safety-monitor)\nconst url = \"https://us-fda-recalls-safety-monitor.p.rapidapi.com/v2/acts/b2b-quant-apis~us-fda-recalls-safety-monitor/run-sync-get-dataset-items\";\nconst options = {\n method: \"POST\",\n headers: {\n \"Content-Type\": \"application/json\",\n \"X-RapidAPI-Host\": \"us-fda-recalls-safety-monitor.p.rapidapi.com\",\n \"X-RapidAPI-Key\": \"\"\n },\n body: JSON.stringify({\"domain\": \"drug\", \"classification\": \"ALL\", \"keyword\": \"semaglutide\", \"state\": \"\", \"maxResults\": 10})\n};\n\nconst response = await fetch(url, options);\nconst data = await response.json();\nconsole.log(data);\n" } ], "x-snippets": { "cURL": "# Primary Synchronous Endpoint: https://us-fda-recalls-safety-monitor.p.rapidapi.com/v2/acts/b2b-quant-apis~us-fda-recalls-safety-monitor/run-sync-get-dataset-items (Gateway Route: https://b2b-quant-rapidapi-gateway.jesleytassili.workers.dev/v1/us-fda-recalls-safety-monitor)\ncurl --request POST \\\n --url \"https://us-fda-recalls-safety-monitor.p.rapidapi.com/v2/acts/b2b-quant-apis~us-fda-recalls-safety-monitor/run-sync-get-dataset-items\" \\\n --header \"Content-Type: application/json\" \\\n --header \"X-RapidAPI-Host: us-fda-recalls-safety-monitor.p.rapidapi.com\" \\\n --header \"X-RapidAPI-Key: \" \\\n --data '{\"domain\": \"drug\", \"classification\": \"ALL\", \"keyword\": \"semaglutide\", \"state\": \"\", \"maxResults\": 10}'", "Python": "import httpx\n\n# Primary Synchronous Endpoint (Gateway Route: https://b2b-quant-rapidapi-gateway.jesleytassili.workers.dev/v1/us-fda-recalls-safety-monitor)\nurl = \"https://us-fda-recalls-safety-monitor.p.rapidapi.com/v2/acts/b2b-quant-apis~us-fda-recalls-safety-monitor/run-sync-get-dataset-items\"\npayload = {\n \"domain\": \"drug\",\n \"classification\": \"ALL\",\n \"keyword\": \"semaglutide\",\n \"state\": \"\",\n \"maxResults\": 10\n}\nheaders = {\n \"Content-Type\": \"application/json\",\n \"X-RapidAPI-Host\": \"us-fda-recalls-safety-monitor.p.rapidapi.com\",\n \"X-RapidAPI-Key\": \"\",\n}\n\nwith httpx.Client(timeout=30.0) as client:\n response = client.post(url, json=payload, headers=headers)\n response.raise_for_status()\n print(response.json())\n", "Node.js": "// Primary Synchronous Endpoint (Gateway Route: https://b2b-quant-rapidapi-gateway.jesleytassili.workers.dev/v1/us-fda-recalls-safety-monitor)\nconst url = \"https://us-fda-recalls-safety-monitor.p.rapidapi.com/v2/acts/b2b-quant-apis~us-fda-recalls-safety-monitor/run-sync-get-dataset-items\";\nconst options = {\n method: \"POST\",\n headers: {\n \"Content-Type\": \"application/json\",\n \"X-RapidAPI-Host\": \"us-fda-recalls-safety-monitor.p.rapidapi.com\",\n \"X-RapidAPI-Key\": \"\"\n },\n body: JSON.stringify({\"domain\": \"drug\", \"classification\": \"ALL\", \"keyword\": \"semaglutide\", \"state\": \"\", \"maxResults\": 10})\n};\n\nconst response = await fetch(url, options);\nconst data = await response.json();\nconsole.log(data);\n" }, "x-backend-secret-header": { "name": "Authorization", "value": "Bearer ", "visibleToSubscriber": false }, "requestBody": { "required": true, "description": "Structured JSON parameters for `us-fda-recalls-safety-monitor`.", "content": { "application/json": { "schema": { "$ref": "#/components/schemas/UsFdaRecallsSafetyMonitorRequest" }, "example": { "domain": "drug", "classification": "ALL", "keyword": "semaglutide", "state": "", "maxResults": 10 } } } }, "responses": { "200": { "description": "Successful synchronous execution of `us-fda-recalls-safety-monitor` returning enriched B2B JSON records.", "headers": { "X-RateLimit-Remaining": { "description": "Remaining requests in the subscriber's monthly plan quota (BASIC=15, PRO=1000, ULTRA=5000, MEGA=25000).", "schema": { "type": "integer", "example": 999 } }, "X-Engine-Version": { "description": "Deterministic B2B engine release version.", "schema": { "type": "string", "example": "3.0.0" } } }, "content": { "application/json": { "schema": { "$ref": "#/components/schemas/UsFdaRecallsSafetyMonitorResponseEnvelope" }, "example": { "status": "succeeded", "actor": "us-fda-recalls-safety-monitor", "engineVersion": "3.0.0", "count": 1, "data": [ { "recallNumber": "D-0026-2027", "eventId": "99867", "domain": "drug", "classification": "Class II", "severityScore": 75, "recallingFirm": "Carolina Infusion, LLC", "city": "Ridgeland", "state": "SC", "country": "United States", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "reportDate": "2026-10-14", "recallInitiationDate": "2026-09-10", "centerClassificationDate": "2026-10-08", "reasonForRecall": "Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.", "productDescription": "SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936", "productQuantity": "82.9 mls - in patient specific syringe dose", "codeInfo": "Lot: 07242026@1, BUD: 9/7/2026; 08032026@20, BUD: 9/17/2026; 08312026@16, BUD: 10/15/2026; 08242026@28, BUD: 10/8/2026; 08072026@16, BUD: 9/21/2026. .", "distributionPattern": "Nationwide within the U.S", "markdownLegalBrief": "# FDA ENFORCEMENT & PRODUCT LIABILITY BRIEF: D-0026-2027\n\n## 1. Executive Risk Summary\n- **Regulatory Domain:** FDA DRUG\n- **Hazard Classification:** Class II (MODERATE / REVERSIBLE HAZARD)\n- **Quantitative Severity Score:** 75/100\n- **Enforcement Status:** Ongoing\n- **Report Date:** 2026-10-14 (Initiated: 2026-09-10)\n\n## 2. Recalling Entity & Jurisdiction\n- **Recalling Firm:** Carolina Infusion, LLC\n- **Location:** Ridgeland, SC (United States)\n- **Action Type:** Voluntary: Firm initiated\n- **Distribution Scope:** Nationwide within the U.S\n\n## 3. Defect & Hazard Analysis\n- **Reason for Recall:** Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.\n- **Affected Product Description:** SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on..." } ] } } } }, "201": { "description": "Synchronous dataset created and returned for `us-fda-recalls-safety-monitor` on Apify Cloud (`HTTP 201`).", "content": { "application/json": { "schema": { "$ref": "#/components/schemas/UsFdaRecallsSafetyMonitorResponseEnvelope" }, "example": { "status": "succeeded", "actor": "us-fda-recalls-safety-monitor", "engineVersion": "3.0.0", "count": 1, "data": [ { "recallNumber": "D-0026-2027", "eventId": "99867", "domain": "drug", "classification": "Class II", "severityScore": 75, "recallingFirm": "Carolina Infusion, LLC", "city": "Ridgeland", "state": "SC", "country": "United States", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "reportDate": "2026-10-14", "recallInitiationDate": "2026-09-10", "centerClassificationDate": "2026-10-08", "reasonForRecall": "Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.", "productDescription": "SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936", "productQuantity": "82.9 mls - in patient specific syringe dose", "codeInfo": "Lot: 07242026@1, BUD: 9/7/2026; 08032026@20, BUD: 9/17/2026; 08312026@16, BUD: 10/15/2026; 08242026@28, BUD: 10/8/2026; 08072026@16, BUD: 9/21/2026. .", "distributionPattern": "Nationwide within the U.S", "markdownLegalBrief": "# FDA ENFORCEMENT & PRODUCT LIABILITY BRIEF: D-0026-2027\n\n## 1. Executive Risk Summary\n- **Regulatory Domain:** FDA DRUG\n- **Hazard Classification:** Class II (MODERATE / REVERSIBLE HAZARD)\n- **Quantitative Severity Score:** 75/100\n- **Enforcement Status:** Ongoing\n- **Report Date:** 2026-10-14 (Initiated: 2026-09-10)\n\n## 2. Recalling Entity & Jurisdiction\n- **Recalling Firm:** Carolina Infusion, LLC\n- **Location:** Ridgeland, SC (United States)\n- **Action Type:** Voluntary: Firm initiated\n- **Distribution Scope:** Nationwide within the U.S\n\n## 3. Defect & Hazard Analysis\n- **Reason for Recall:** Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.\n- **Affected Product Description:** SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on..." } ] } } } }, "400": { "description": "Bad Request — Invalid JSON payload or schema validation error.", "content": { "application/json": { "schema": { "$ref": "#/components/schemas/ErrorResponse" }, "example": { "status": "error", "code": 400, "message": "Invalid JSON request body." } } } }, "403": { "description": "Forbidden — Missing or invalid `X-RapidAPI-Proxy-Secret` / `X-Zyla-Proxy-Secret` header (Anti-Bypass Protection).", "content": { "application/json": { "schema": { "$ref": "#/components/schemas/ErrorResponse" }, "example": { "status": "forbidden", "code": 403, "message": "Direct access denied. Requests must originate from RapidAPI Hub or Zyla API Hub with a valid Proxy-Secret." } } } }, "429": { "description": "Too Many Requests — Monthly plan quota exceeded (e.g., BASIC Freemium 15 req/month hard limit).", "content": { "application/json": { "schema": { "$ref": "#/components/schemas/ErrorResponse" }, "example": { "status": "quota_exceeded", "code": 429, "message": "Monthly request quota exceeded for BASIC plan (15 req/month hard limit). Upgrade to PRO ($19/mo), ULTRA ($49/mo), or MEGA ($149/mo)." } } } } } } }, "/v1/us-fda-recalls-safety-monitor/health": { "get": { "operationId": "health_us_fda_recalls_safety_monitor", "summary": "Health & SLA Check for US FDA Recalls & Safety Monitor (Food, Drug & Devices)", "description": "Immediate `HTTP 200` status and metadata health check for `us-fda-recalls-safety-monitor` on RapidAPI Studio and Zyla API Hub (`GET https://api.apify.com/v2/acts/b2b-quant-apis~us-fda-recalls-safety-monitor` and `GET /v1/us-fda-recalls-safety-monitor/health`) without starting a container build or run.", "tags": [ "Medical" ], "responses": { "200": { "description": "Engine online and ready (`HTTP 200 JSON`).", "content": { "application/json": { "schema": { "type": "object", "properties": { "status": { "type": "string", "example": "ok" }, "actor": { "type": "string", "example": "us-fda-recalls-safety-monitor" }, "engineVersion": { "type": "string", "example": "3.0.0" }, "category": { "type": "string", "example": "Medical" }, "data": { "type": "object", "additionalProperties": true, "example": { "name": "us-fda-recalls-safety-monitor", "username": "b2b-quant-apis", "isPublic": true } } } }, "example": { "status": "ok", "actor": "us-fda-recalls-safety-monitor", "engineVersion": "3.0.0", "category": "Medical", "data": { "name": "us-fda-recalls-safety-monitor", "username": "b2b-quant-apis", "isPublic": true } } } } } } } } }, "components": { "securitySchemes": { "ApifyCloudBearerAuth": { "type": "http", "scheme": "bearer", "bearerFormat": "APIFY_API_TOKEN", "description": "Backend Secret Header (`Authorization: Bearer `) injected invisibly by RapidAPI Studio and Zyla API Hub proxy when calling https://api.apify.com." }, "RapidAPIProxySecret": { "type": "apiKey", "in": "header", "name": "X-RapidAPI-Proxy-Secret", "description": "RapidAPI Hub shared proxy secret verified in constant time via hmac.compare_digest." }, "ZylaProxySecret": { "type": "apiKey", "in": "header", "name": "X-Zyla-Proxy-Secret", "description": "Zyla API Hub shared proxy secret verified in constant time via hmac.compare_digest." }, "RapidAPISubscriberKey": { "type": "apiKey", "in": "header", "name": "X-RapidAPI-Key", "description": "Subscriber API Key injected by RapidAPI Hub or Zyla API Hub." } }, "schemas": { "UsFdaRecallsSafetyMonitorRequest": { "type": "object", "title": "US FDA Recalls & Safety Monitor (Food, Drug & Devices) Request Schema", "description": "Configure the FDA regulatory domain, hazard classification filter, search keywords, and US state filter to extract enriched FDA recall intelligence.", "properties": { "domain": { "type": "string", "title": "FDA Regulatory Domain", "description": "Select the FDA enforcement category to monitor: food, drug, or device.", "default": "food", "enum": [ "food", "drug", "device" ], "example": "drug" }, "classification": { "type": "string", "title": "Hazard Classification", "description": "Filter recalls by FDA hazard severity class (Class I = highest life-threatening risk, Class II = moderate/reversible risk, Class III = low risk).", "default": "ALL", "enum": [ "ALL", "Class I", "Class II", "Class III" ], "example": "ALL" }, "keyword": { "type": "string", "title": "Search Keyword (Optional)", "description": "Optional search keyword in reason_for_recall or product_description (e.g., 'salmonella', 'listeria', 'undeclared', 'pacemaker').", "default": "", "example": "semaglutide" }, "state": { "type": "string", "title": "US State Code (Optional)", "description": "Optional 2-letter US State of recalling firm (e.g., 'CA', 'NY', 'TX', 'FL').", "default": "", "example": "" }, "maxResults": { "type": "integer", "title": "Maximum Results", "description": "Maximum number of recall enforcement records to fetch (1 to 200).", "default": 15, "minimum": 1, "maximum": 200, "example": 10 } }, "required": [ "domain" ], "example": { "domain": "drug", "classification": "ALL", "keyword": "semaglutide", "state": "", "maxResults": 10 } }, "UsFdaRecallsSafetyMonitorRecord": { "type": "object", "title": "US FDA Recalls & Safety Monitor (Food, Drug & Devices) Output Record", "description": "Enriched B2B dataset item returned by `us-fda-recalls-safety-monitor`.", "properties": { "recallNumber": { "type": "string", "title": "Recall Number", "description": "Official FDA recall event or enforcement number.", "example": "D-0026-2027" }, "domain": { "type": "string", "title": "FDA Domain", "description": "Regulatory domain (food, drug, device).", "example": "drug" }, "classification": { "type": "string", "title": "Classification", "description": "FDA hazard severity class (Class I, Class II, Class III).", "example": "Class II" }, "severityScore": { "type": "integer", "title": "Severity Score (0-100)", "description": "Quantitative risk score based on hazard class, recall status, and nationwide distribution.", "example": 75 }, "recallingFirm": { "type": "string", "title": "Recalling Firm", "description": "Manufacturer, distributor, or firm initiating the recall.", "example": "Carolina Infusion, LLC" }, "state": { "type": "string", "title": "State", "description": "2-letter US State code of the recalling firm.", "example": "SC" }, "status": { "type": "string", "title": "Recall Status", "description": "Current enforcement status (Ongoing, Completed, Terminated, Pending).", "example": "Ongoing" }, "reportDate": { "type": "string", "title": "Report Date", "description": "Formatted FDA enforcement report date (YYYY-MM-DD).", "example": "2026-10-14" }, "reasonForRecall": { "type": "string", "title": "Reason for Recall", "description": "Official FDA summary of the defect, contamination, or safety hazard.", "example": "Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product." }, "productDescription": { "type": "string", "title": "Product Description", "description": "Detailed description of the recalled product, packaging, and brand.", "example": "SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936" }, "markdownLegalBrief": { "type": "string", "title": "Markdown Legal & Compliance Brief", "description": "Ready-to-use Markdown dossier for Product Liability litigation and supply chain QA.", "example": "# FDA ENFORCEMENT & PRODUCT LIABILITY BRIEF: D-0026-2027\n\n## 1. Executive Risk Summary\n- **Regulatory Domain:** FDA DRUG\n- **Hazard Classification:** Class II (MODERATE / REVERSIBLE HAZARD)\n- **Quantitative Severity Score:** 75/100\n- **Enforcement Status:** Ongoing\n- **Report Date:** 2026-10-14 (Initiated: 2026-09-10)\n\n## 2. Recalling Entity & Jurisdiction\n- **Recalling Firm:** Carolina Infusion, LLC\n- **Location:** Ridgeland, SC (United States)\n- **Action Type:** Voluntary: Firm initiated\n- **Distribution Scope:** Nationwide within the U.S\n\n## 3. Defect & Hazard Analysis\n- **Reason for Recall:** Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.\n- **Affected Product Description:** SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on..." }, "eventId": { "type": "string", "title": "eventId", "description": "eventId returned by US FDA Recalls & Safety Monitor (Food, Drug & Devices).", "example": "99867" }, "city": { "type": "string", "title": "city", "description": "city returned by US FDA Recalls & Safety Monitor (Food, Drug & Devices).", "example": "Ridgeland" }, "country": { "type": "string", "title": "country", "description": "country returned by US FDA Recalls & Safety Monitor (Food, Drug & Devices).", "example": "United States" }, "voluntaryMandated": { "type": "string", "title": "voluntaryMandated", "description": "voluntaryMandated returned by US FDA Recalls & Safety Monitor (Food, Drug & Devices).", "example": "Voluntary: Firm initiated" }, "recallInitiationDate": { "type": "string", "title": "recallInitiationDate", "description": "recallInitiationDate returned by US FDA Recalls & Safety Monitor (Food, Drug & Devices).", "example": "2026-09-10" }, "centerClassificationDate": { "type": "string", "title": "centerClassificationDate", "description": "centerClassificationDate returned by US FDA Recalls & Safety Monitor (Food, Drug & Devices).", "example": "2026-10-08" }, "productQuantity": { "type": "string", "title": "productQuantity", "description": "productQuantity returned by US FDA Recalls & Safety Monitor (Food, Drug & Devices).", "example": "82.9 mls - in patient specific syringe dose" }, "codeInfo": { "type": "string", "title": "codeInfo", "description": "codeInfo returned by US FDA Recalls & Safety Monitor (Food, Drug & Devices).", "example": "Lot: 07242026@1, BUD: 9/7/2026; 08032026@20, BUD: 9/17/2026; 08312026@16, BUD: 10/15/2026; 08242026@28, BUD: 10/8/2026; 08072026@16, BUD: 9/21/2026. ." }, "distributionPattern": { "type": "string", "title": "distributionPattern", "description": "distributionPattern returned by US FDA Recalls & Safety Monitor (Food, Drug & Devices).", "example": "Nationwide within the U.S" } }, "example": { "recallNumber": "D-0026-2027", "eventId": "99867", "domain": "drug", "classification": "Class II", "severityScore": 75, "recallingFirm": "Carolina Infusion, LLC", "city": "Ridgeland", "state": "SC", "country": "United States", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "reportDate": "2026-10-14", "recallInitiationDate": "2026-09-10", "centerClassificationDate": "2026-10-08", "reasonForRecall": "Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.", "productDescription": "SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936", "productQuantity": "82.9 mls - in patient specific syringe dose", "codeInfo": "Lot: 07242026@1, BUD: 9/7/2026; 08032026@20, BUD: 9/17/2026; 08312026@16, BUD: 10/15/2026; 08242026@28, BUD: 10/8/2026; 08072026@16, BUD: 9/21/2026. .", "distributionPattern": "Nationwide within the U.S", "markdownLegalBrief": "# FDA ENFORCEMENT & PRODUCT LIABILITY BRIEF: D-0026-2027\n\n## 1. Executive Risk Summary\n- **Regulatory Domain:** FDA DRUG\n- **Hazard Classification:** Class II (MODERATE / REVERSIBLE HAZARD)\n- **Quantitative Severity Score:** 75/100\n- **Enforcement Status:** Ongoing\n- **Report Date:** 2026-10-14 (Initiated: 2026-09-10)\n\n## 2. Recalling Entity & Jurisdiction\n- **Recalling Firm:** Carolina Infusion, LLC\n- **Location:** Ridgeland, SC (United States)\n- **Action Type:** Voluntary: Firm initiated\n- **Distribution Scope:** Nationwide within the U.S\n\n## 3. Defect & Hazard Analysis\n- **Reason for Recall:** Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.\n- **Affected Product Description:** SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on..." } }, "UsFdaRecallsSafetyMonitorResponseEnvelope": { "type": "object", "title": "US FDA Recalls & Safety Monitor (Food, Drug & Devices) Synchronous Response Envelope", "required": [ "status", "actor", "count", "data" ], "properties": { "status": { "type": "string", "example": "succeeded" }, "actor": { "type": "string", "example": "us-fda-recalls-safety-monitor" }, "marketplace": { "type": "string", "example": "rapidapi_zyla_hub" }, "engineVersion": { "type": "string", "example": "3.0.0" }, "count": { "type": "integer", "example": 1 }, "data": { "type": "array", "items": { "$ref": "#/components/schemas/UsFdaRecallsSafetyMonitorRecord" } } }, "example": { "status": "succeeded", "actor": "us-fda-recalls-safety-monitor", "engineVersion": "3.0.0", "count": 1, "data": [ { "recallNumber": "D-0026-2027", "eventId": "99867", "domain": "drug", "classification": "Class II", "severityScore": 75, "recallingFirm": "Carolina Infusion, LLC", "city": "Ridgeland", "state": "SC", "country": "United States", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "reportDate": "2026-10-14", "recallInitiationDate": "2026-09-10", "centerClassificationDate": "2026-10-08", "reasonForRecall": "Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.", "productDescription": "SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936", "productQuantity": "82.9 mls - in patient specific syringe dose", "codeInfo": "Lot: 07242026@1, BUD: 9/7/2026; 08032026@20, BUD: 9/17/2026; 08312026@16, BUD: 10/15/2026; 08242026@28, BUD: 10/8/2026; 08072026@16, BUD: 9/21/2026. .", "distributionPattern": "Nationwide within the U.S", "markdownLegalBrief": "# FDA ENFORCEMENT & PRODUCT LIABILITY BRIEF: D-0026-2027\n\n## 1. Executive Risk Summary\n- **Regulatory Domain:** FDA DRUG\n- **Hazard Classification:** Class II (MODERATE / REVERSIBLE HAZARD)\n- **Quantitative Severity Score:** 75/100\n- **Enforcement Status:** Ongoing\n- **Report Date:** 2026-10-14 (Initiated: 2026-09-10)\n\n## 2. Recalling Entity & Jurisdiction\n- **Recalling Firm:** Carolina Infusion, LLC\n- **Location:** Ridgeland, SC (United States)\n- **Action Type:** Voluntary: Firm initiated\n- **Distribution Scope:** Nationwide within the U.S\n\n## 3. Defect & Hazard Analysis\n- **Reason for Recall:** Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.\n- **Affected Product Description:** SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on..." } ] } }, "ErrorResponse": { "type": "object", "required": [ "status", "code", "message" ], "properties": { "status": { "type": "string", "example": "error" }, "code": { "type": "integer", "example": 403 }, "message": { "type": "string", "example": "Direct access denied." } } } } } }