WhichRecall
Class IIReported 2025-09-10

chlorproMAZINE Hydrochloride Tablets, USP, 50 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 69238-1058-1.

Recalled by Amneal Pharmaceuticals, LLC

Reason for Recall

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism

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No micro-organism was detected on any tablets.

Recall Number
D-0617-2025
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2025-08-18
Reported
2025-09-10
Distribution
Distributed Nationwide in the USA
Code Info
Lot: AM240147, AM240148, Exp Date 01/31/2027; Lot AM240664, AM240665, Exp Date 04/30/2027.
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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