Drug product
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1056-1.
D-0616-2025
Product summary
- Event
- Event 97438
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7,228 100-count bottles
- Official record key
drug-enforcement:D-0616-2025
Official wording
Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Code information: Lot AM240617, AM240618, Exp Date 04/30/2027
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
foreign substance