Drug recall D-0616-2025
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.
Reason for recall
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.
Lots and codes
Lot AM240617, AM240618, Exp Date 04/30/2027
Recall details
- Recalling firm
- Amneal Pharmaceuticals, LLC, Bridgewater, NJ
- Quantity
- 7,228 100-count bottles
- Distribution
- Distributed Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 18, 2025
Related products
- Chlorpromazine Hydrochloride – drug information
- NDC 69238-1060 Chlorpromazine Hydrochloride · Chlorpromazine Hydrochloride 100 mg/1 · Amneal Pharmaceuticals NY LLC
- NDC 69238-1062 Chlorpromazine Hydrochloride · Chlorpromazine Hydrochloride 200 mg/1 · Amneal Pharmaceuticals NY LLC
- NDC 69238-1054 Chlorpromazine Hydrochloride · Chlorpromazine Hydrochloride 10 mg/1 · Amneal Pharmaceuticals NY LLC
- NDC 69238-1056 Chlorpromazine Hydrochloride · Chlorpromazine Hydrochloride 25 mg/1 · Amneal Pharmaceuticals NY LLC
- NDC 69238-1058 Chlorpromazine Hydrochloride · Chlorpromazine Hydrochloride 50 mg/1 · Amneal Pharmaceuticals NY LLC