Drug Enforcement D-0617-2025

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.

Status

Ongoing

Classification

Class II

Report Date

September 10, 2025

Termination Date

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Product Information

Product description
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.
Product quantity
13,130 100-count bottles
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. No micro-organism was detected on any tablets.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Distributed Nationwide in the USA

Location & Firm

Recalling firm
Amneal Pharmaceuticals, LLC
Address
400 Crossing Blvd Fl 3, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0617-2025
Event ID
97438
Recall initiation date
August 18, 2025
Center classification date
September 4, 2025
Code info
Lot: AM240147, AM240148, Exp Date 01/31/2027; Lot AM240664, AM240665, Exp Date 04/30/2027.
More code info
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