Drug recall D-0647-2025
Product
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) blisterpacks, NDC: 60687-430-65; (Individual Dose NDC: 60687-430-11); b) 100 (10x10) blisterpacks, NDC: 60687-430-01, (Individual Dose NDC: 60687-430-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.
Reason for recall
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Lots and codes
Lot: a)1020919, 1021133, Exp 09/30/2026; 1021447, Exp 10/31/2026; 1021741, 1022202, Exp 11/30/2026; 1022474, Exp 12/31/2026 Lot: b) 1020460, exp 08/31/2026; 1022417, exp 12/31/2026
Recall details
- Recalling firm
- Amerisource Health Services LLC, Columbus, OH
- Quantity
- 2,708 cartons
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 27, 2025
Related products
- Chlorpromazine Hydrochloride – drug information
- NDC 60687-419 Chlorpromazine Hydrochloride · Chlorpromazine Hydrochloride 10 mg/1 · American Health Packaging
- NDC 60687-463 Chlorpromazine Hydrochloride · Chlorpromazine Hydrochloride 200 mg/1 · American Health Packaging
- NDC 60687-452 Chlorpromazine Hydrochloride · Chlorpromazine Hydrochloride 100 mg/1 · American Health Packaging
- NDC 60687-430 Chlorpromazine Hydrochloride · Chlorpromazine Hydrochloride 25 mg/1 · American Health Packaging
- NDC 60687-441 Chlorpromazine Hydrochloride · Chlorpromazine Hydrochloride 50 mg/1 · American Health Packaging