Chlorpromazine 50 mg tablets recalled over micro-organism on packaging coil
Amneal chlorpromazine hydrochloride tablets, 50 mg, are recalled because a micro-organism was detected on a lot of auxiliary polyester coil used in packaging. No micro-organism was found on any tablets.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers precautionary recalls; the contamination was found on a packaging component and the notice states no micro-organism was detected on any tablets.
Plain-English summary
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, in 100-count bottles and available on prescription only, manufactured by Amneal Pharmaceuticals Pvt. Ltd. in Ahmedabad, India and distributed by Amneal Pharmaceuticals LLC of Bridgewater, New Jersey, are being recalled. Affected lots are AM240147 and AM240148 expiring 01/31/2027, and AM240664 and AM240665 expiring 04/30/2027. The recall covers 13,130 100-count bottles distributed nationwide.
The recall was issued for the presence of a foreign substance: a specific lot of auxiliary polyester coil used in product packaging was found to contain a micro-organism. The notice states that no micro-organism was detected on any tablets. The FDA classified the action as Class II.
Patients should check the lot number on their bottle against the recall and should speak to their pharmacist about a replacement supply before stopping a prescribed medicine.
The recalled product
- Product
- CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
- Brand
- CHLORPROMAZINE HYDROCHLORIDE
- Manufacturer
- Amneal Pharmaceuticals, LLC
- Category
- Drug — Central Nervous System
- Hazard
- packaging-contamination
- foreign-substance
- prescription-drug
- class-ii
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot: AM240147
- AM240148
- Exp Date 01/31/2027
- Lot AM240664
- AM240665
- Exp Date 04/30/2027.
UPCs (2)
- 0369238105612
- 0369238106213
Distribution
Distributed nationwide across the United States.
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