Packaged chlorpromazine cartons recalled over micro-organism on packaging coil
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, in blister cartons from American Health Packaging, are recalled because a micro-organism was found on a lot of packaging coil. 873 cartons are affected.
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: Rubric level 2 covers precautionary recalls; the contamination was found on a packaging component and the notice states no micro-organism was detected on any tablets.
Plain-English summary
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, in 100-tablet (10x10) blister packs per carton and available on prescription only, distributed by American Health Packaging of Columbus, Ohio, NDC 60687-463-01 with individual dose NDC 60687-463-11, are being recalled. Affected lots are 1021640 expiring 10/31/2026 and 1022639 expiring 01/31/2027. The recall covers 873 cartons distributed nationwide.
The recall was issued for the presence of a foreign substance: a specific lot of auxiliary polyester coil used in product packaging at the manufacturing site was found to contain a micro-organism. The notice states that no micro-organism was detected on any tablets. The FDA classified the action as Class II.
Patients should check the lot number on their carton against the recall and should speak to their pharmacist about a replacement supply before stopping a prescribed medicine.
The recalled product
- Product
- CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
- Brand
- CHLORPROMAZINE HYDROCHLORIDE
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug — Central Nervous System
- Affected units
- 873
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.
Part of a larger recall action
This product is one of 4 recalled by Amerisource Health Services LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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