D-0649-2025 Class II Ongoing
FDA drug recall D-0649-2025 was initiated by Amerisource Health Services LLC on August 27, 2025 and is designated Class II. 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 d… The recall status is ongoing. Affected quantity: 1,757 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- September 24, 2025
- Initiation Date
- August 27, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,757 cartons
Product Description
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)
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 1021652, Exp 10/31/2026; 1022539, Exp 01/31/2027; 1023666, Exp 03/31/2027