Chlorpromazine Hydrochloride Tablets Recalled for Foreign Substance in Packaging Material
Amerisource Health Services is recalling Chlorpromazine Hydrochloride 200 mg tablets distributed nationwide due to a micro-organism detected in auxiliary packaging material. The tablets themselves were not contaminated.
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: This is an FDA Class II recall with no reported illnesses or injuries. The micro-organism was detected only on auxiliary packaging material, not on the tablets themselves. Per the severity rubric, this constitutes low-risk contamination with no reported harm, fitting the Moderate classification.
Plain-English summary
Amerisource Health Services LLC, operating as American Health Packaging, is recalling Chlorpromazine Hydrochloride Tablets, USP, 200 mg in 100-tablet (10x10) blisterpack cartons. A total of 873 cartons were distributed nationwide in the USA.
A micro-organism was detected in a specific lot of auxiliary polyester coil used in product packaging at the manufacturing site. However, no micro-organism was detected on any tablets. This is an FDA Class II recall.
The recall affects two lots: Lot 1021640 (expiration 10/31/2026) and Lot 1022639 (expiration 01/31/2027). Patients and healthcare providers should verify the lot numbers on their medication supplies against these numbers.
Patients should not discontinue their Chlorpromazine Hydrochloride medication without consulting their healthcare provider. For recall information or questions, contact Amerisource Health Services or American Health Packaging, Columbus, Ohio 43217.
The recalled product
- Product
- CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
- Brand
- CHLORPROMAZINE HYDROCHLORIDE
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug
- Hazard
- foreign-substance
- 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 (4)
- Lot: 1021640
- Exp 10/31/2026
- 1022639
- Exp 01/31/2027
Distribution
Distributed nationwide across the United States.
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