Amneal Pharmaceuticals LLC is recalling 7,228 bottles of CHLORPROMAZINE HYDROCHLORIDE tablets sold nationwide in the United States. Packaging coils used in the bottles tested positive for a microorganism, though no tablets were contaminated. Stop using this product immediately and contact Amneal or your healthcare provider for guidance.
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.
Consumers and healthcare providers should stop using this product immediately. Contact Amneal Pharmaceuticals, LLC or your healthcare provider for guidance. Notification method: Letter
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Chlorpromazine hydrochloride is an antipsychotic medication used to treat certain psychiatric conditions. It is sold as prescription-only medication.
A manufacturing packaging coil contained a microorganism. The tablets themselves were not contaminated, but the packaging defect raises contamination risk.
This recall is not indicated as part of a broader industry pattern.
Patients with affected lots should stop using the product and await guidance. The recall covers 7,228 bottles distributed nationwide in the U.S.
NDC 69238-1056-1; Lot AM240617; Lot AM240618; Exp 04/30/2027; Manufactured in India; Distributed by Amneal Pharmaceuticals LLC, NJ.
Refunds/replacements expected in 4-6 weeks after eligibility is confirmed.
Keep recall letter, bottle labels, lot numbers, and any correspondence with Amneal for records.
NDC 69238-1056-1. Lot AM240617 and Lot AM240618. Expiration date 04/30/2027. Quantity recalled: 7,228 bottles of 100-count each. Manufactured by Amneal Pharmaceuticals Pvt. Ltd. in Ahmedabad, India. Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. Sold nationwide in the U.S. Rx Only. Category: Health & Personal Care; Drugs & Medications.
No injuries or incidents have been reported.
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