Chlorpromazine Hydrochloride Tablets Recalled for Contaminated Packaging
Amneal Pharmaceuticals recalls specific lots of Chlorpromazine Hydrochloride 25 mg tablets due to a micro-organism detected in packaging material. The medication itself remains uncontaminated.
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: FDA Class II classification indicates agency action is required. However, the contamination is confined to packaging material, with no micro-organism detected on the tablets themselves and no reported illnesses or injuries. This is a precautionary packaging defect recall.
Plain-English summary
Amneal Pharmaceuticals, LLC is recalling specific lots of Chlorpromazine Hydrochloride Tablets, USP 25 mg, distributed nationwide. The recall was initiated due to the detection of a micro-organism in the packaging material.
The contamination was identified in a specific lot of auxiliary polyester coil used in product packaging. Testing confirmed that no micro-organism was detected on the tablets themselves.
The affected lots are AM240617 and AM240618, with an expiration date of 04/30/2027. A total of 7,228 100-count bottles are involved in this recall.
Patients or healthcare providers with questions about this recall should contact Amneal Pharmaceuticals or consult their pharmacy.
The recalled product
- Product
- CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
- Brand
- CHLORPROMAZINE HYDROCHLORIDE
- Manufacturer
- Amneal Pharmaceuticals, LLC
- Category
- Drug
- Hazard
- contamination
- packaging-defect
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 (3)
- Lot AM240617
- AM240618
- Exp Date 04/30/2027
UPCs (2)
- 0369238105612
- 0369238106213
Distribution
Distributed nationwide across the United States.
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