Chlorpromazine Hydrochloride 100 mg tablets recalled for packaging contamination
Amerisource Health Services is recalling 1,757 cartons of Chlorpromazine Hydrochloride 100 mg tablets due to detection of a micro-organism in packaging material. The organism was not 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: This is an FDA Class II recall with no reported illnesses or injuries. The micro-organism was detected only in packaging material, not on the tablets themselves, making the hazard theoretical rather than confirmed. This aligns with a precautionary recall involving low-risk contamination.
Plain-English summary
Amerisource Health Services LLC is recalling 1,757 cartons of Chlorpromazine Hydrochloride Tablets, USP, 100 mg, distributed nationwide in the United States. The recall applies to carton NDC 60687-452-01 and individual unit dose blister pack NDC 60687-452-11.
A micro-organism was detected in the auxiliary polyester coil used in the product packaging at the manufacturing site. Quality control testing identified the organism during routine inspection of packaging material. However, testing confirmed that the micro-organism was not detected on the actual tablets.
The affected lots are: Lot 1021652 (expiration 10/31/2026), Lot 1022539 (expiration 01/31/2027), and Lot 1023666 (expiration 03/31/2027). Patients, healthcare providers, and pharmacies with these lots should contact Amerisource Health Services for instructions on how to return or discard the affected products.
The recalled product
- Product
- CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
- Brand
- CHLORPROMAZINE HYDROCHLORIDE
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug — Prescription Drug
- Hazard
- foreign-substance
- 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: 1021652
- Exp 10/31/2026
- 1022539
- Exp 01/31/2027
- 1023666
- Exp 03/31/2027
Distribution
Distributed nationwide across the United States.
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