Chlorpromazine Hydrochloride Tablets Recalled Due to Microbial Contamination in Packaging
A specific lot of Chlorpromazine Hydrochloride 200mg tablets is being recalled because the auxiliary polyester coil packaging material was detected with a microorganism. No contamination was found on the tablets themselves.
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: Class II recall with low-risk contamination limited to packaging material; no microorganism detected on tablets themselves; no reported illnesses or injuries; represents a precautionary manufacturing quality control measure.
Plain-English summary
Amneal Pharmaceuticals, LLC has recalled specific lots of Chlorpromazine Hydrochloride Tablets, USP, 200 mg, distributed nationwide in the United States. The recall was initiated due to the detection of a microorganism in a specific lot of auxiliary polyester coil used in the product packaging.
During quality control testing, a microorganism was detected in the polyester coil material used in the packaging. However, testing confirmed that no microorganism was detected on any of the tablets themselves, indicating the contamination is limited to the packaging material.
The recalled product includes Lot Numbers AM240336 and AM240337, with an expiration date of 02/28/2027. A total of 3,363 100-count bottles were distributed nationwide.
Patients currently taking this medication should consult their healthcare provider or pharmacist regarding this recall. Consumers who have bottles from the affected lots should not discard them without guidance from their pharmacist or healthcare provider.
The recalled product
- Product
- CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
- Brand
- CHLORPROMAZINE HYDROCHLORIDE
- Manufacturer
- Amneal Pharmaceuticals, LLC
- Category
- Drug
- Hazard
- microbial-contamination
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: AM240336
- AM240337
- Exp Date 02/28/2027.
UPCs (2)
- 0369238105612
- 0369238106213
Distribution
Distributed nationwide across the United States.
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