Chlorpromazine 100 mg tablets recalled over micro-organism on packaging coil
Amneal chlorpromazine hydrochloride tablets, 100 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, 100 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 AM240334 and AM240335 expiring 02/28/2027, and AM241031 expiring 06/30/2027. The recall covers 14,923 100-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 (5)
- Lot: AM240334
- AM240335
- Exp Date 02/28/2027
- AM241031
- Exp Date 06/30/2027.
UPCs (2)
- 0369238105612
- 0369238106213
Distribution
Distributed nationwide across the United States.
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