Chlorpromazine Hydrochloride tablets distributed nationwide by American Health Packaging are recalled after a polyester coil used in packaging showed presence of a micro-organism in a specific lot. No tablets were contaminated. Consumers and healthcare providers should stop using this product immediately and contact Amerisource Health Services LLC for guidance.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Consumers and healthcare providers should stop using this product immediately. Contact Amerisource Health Services LLC or your healthcare provider for guidance. Notification method: Letter
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Chlorpromazine hydrochloride is an antipsychotic medication used to treat certain psychiatric conditions. It is distributed to healthcare facilities and pharmacies.
A foreign substance from packaging coil carried a microorganism. Tablets themselves were free of microorganisms.
This recall is not part of a broader pattern at this time.
No injuries reported. Consumers should stop using the affected lots and await guidance.
FDA recall page D-0649-2025 and enforcement reports
Refund or replacement notification via letter; timeline not specified
Save recall letter, take photos of packaging and lot codes
Product: Chlorpromazine Hydrochloride Tablets, USP 100 mg. Packaging: 100 tablets per carton, 10x10 blister packs. Distribution: Nationwide in the USA. Distributor: American Health Packaging, Columbus, OH. Carton NDC: 60687-452-01. Individual NDC: 60687-452-11. Quantity recalled: 1,757 cartons. Lot numbers and expirations in use: 1021652 (Exp 10/31/2026), 1022539 (Exp 01/31/2027), 1023666 (Exp 03/31/2027).
No injuries reported. The hazard is contamination risk; no patient injuries documented in the recall notice.
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