FDAHealthAugust 27, 2025
Amerisource Health Services LLC — chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC#:
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 27, 2025
Nationwide in the USA
What's affected?
- Product
- chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC#: 60687-463-01 (Individual Dose NDC: 60687-463-11)
- Lot code
- 1021640
Additional details
Lot: 1021640, Exp 10/31/2026; 1022639, Exp 01/31/2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 873 cartons.
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