Drug 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.
D-0917-2023
Product summary
- Event
- Event 92639
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2348 vials
- Official record key
drug-enforcement:D-0917-2023
Official wording
Reason: Presence of Particulate Matter: Particulate matter identified as fiber.
Code information: Lot #: M2210154 Exp. date 06/2025; M2212575 Exp. date 08/2025
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter