Recalls / Class II
Class IID-0917-2023
Product
Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-512-43.
- Brand name
- Atropine Sulfate
- Generic name
- Atropine Sulfate
- Active ingredient
- Atropine Sulfate
- Route
- Endotracheal, Intramedullary, Intramuscular, Intravenous, Subcutaneous
- NDC
- 16729-512
- FDA application
- ANDA213424
- Affected lot / code info
- Lot #: M2210154 Exp. date 06/2025; M2212575 Exp. date 08/2025
Why it was recalled
Presence of Particulate Matter: Particulate matter identified as fiber.
Recalling firm
- Firm
- Accord Healthcare, Inc.
- Manufacturer
- Accord Healthcare Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1009 Slater Rd Ste 210B, N/A, Durham, North Carolina 27703-8446
Distribution
- Quantity
- 2348 vials
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2023-07-03
- FDA classified
- 2023-07-13
- Posted by FDA
- 2023-07-19
- Terminated
- 2024-10-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0917-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.