FDA Recalls Chlorpromazine Hydrochloride Tablets Due to Packaging Contamination
Amerisource Health Services is recalling 1,062 cartons of chlorpromazine hydrochloride tablets after a micro-organism was detected in packaging material during manufacturing. No micro-organism was found on the tablets themselves.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall. A micro-organism was detected in packaging material used during manufacturing, creating a potential contamination pathway, though testing showed no contamination of the tablets and no illnesses have been reported.
Plain-English summary
Amerisource Health Services LLC is recalling 1,062 cartons of chlorpromazine hydrochloride tablets, USP, 50 mg (carton NDC 60687-441-01) nationwide after a micro-organism was detected in an auxiliary polyester coil used in the packaging process at the manufacturing facility.
The affected lots are Lot 1022159 (expires 12/31/2026), Lot 1023299 (expires 03/31/2027), and Lot 1024057 (expires 04/30/2027). While a micro-organism was detected in the packaging material, testing of the actual tablets showed no micro-organism contamination.
The recalled product is a prescription oral medication distributed by American Health Packaging in Columbus, Ohio, and was distributed nationwide in the United States.
Patients currently taking this medication should not stop without consulting their healthcare provider. Pharmacies and healthcare providers are advised to check their inventory for affected lots and quarantine them. Patients or healthcare providers with questions should contact Amerisource Health Services.
The recalled product
- Product
- CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
- Brand
- CHLORPROMAZINE HYDROCHLORIDE
- Manufacturer
- Amerisource Health Services 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 (6)
- Lot: 1022159
- exp 12/31/2026
- 1023299
- exp 03/31/2027
- 1024057
- Exp 04/30/2027
Distribution
Distributed nationwide across the United States.
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