FDAHealthAugust 18, 2025
Amneal Pharmaceuticals, LLC — chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 18, 2025
Distributed Nationwide in the USA
What's affected?
- Product
- chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1060-1.
- UPC
- 0369238105612
- Lot code
- AM240334
Additional details
Lot: AM240334, AM240335, Exp Date 02/28/2027, AM241031, Exp Date 06/30/2027.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 14,923 100-count bottles.
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