A high-severity recall covers chlorpromazine hydrochloride tablets distributed nationwide by American Health Packaging. A foreign substance linked to a polyester coil packaging component was detected at the manufacturing site. No tablets were contaminated. Stop using the product and contact the distributor 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 psychotic disorders. It is typically prescribed by healthcare providers. The packaging involves blister packs and carton packaging.
A foreign substance associated with an auxiliary polyester coil packaging component was detected at the manufacturing site. No micro-organism was found on tablets.
This recall appears not to be part of a broader industry pattern.
High severity due to potential packaging contamination risk. Immediate cessation of use advised.
FDA enforcement report D-0648-2025 and recall notices
Refunds/replacements will be processed after recall communications, typically weeks
Keep all recall letters, packaging, and prescription records
Product: Chlorpromazine Hydrochloride Tablets, USP 50 mg. Pack: 100 tablets per blisterpack, 10x10 blisters. Carton: 50 tablets in carton, NDC 60687-441-01, individual-dose NDC 60687-441-11. Distributor: Amerisource Health Services LLC doing business as American Health Packaging, Columbus, Ohio 43217. Quantity: 1,062 cartons. Distribution: Nationwide in the USA. Status: Active recall as of 2025-09-24.
No tablets were contaminated with micro-organisms. The notice indicates a foreign substance risk tied to packaging materials.
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American Health Packaging recalled 873 cartons of Chlorpromazine Hydrochloride Tablets, USP, 200 mg, after foreign substances were detected in product packaging. A specific lot of auxiliary polyester coil contained a micro-organism, posing a high health risk. Consumers should stop using the product immediately and contact their healthcare provider for guidance.
A recall of chlorpromazine hydrochloride tablets is active nationwide in the United States. A specific lot of packaging material to coils used in manufacturing contained a foreign substance with a microorganism detected. Tablets themselves tested negative for microorganisms. Consumers and healthcare providers should stop using the product immediately and contact Amerisource Health Services LLC or
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.
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