Drug product
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 60687-452-01 (Individual unit dose blister pack NDC: 60687-452-11)
D-0649-2025
Product summary
- Event
- Event 97533
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,757 cartons
- Official record key
drug-enforcement:D-0649-2025
Official wording
Reason: 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.
Code information: Lot: 1021652, Exp 10/31/2026; 1022539, Exp 01/31/2027; 1023666, Exp 03/31/2027
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
foreign substance