Amneal Pharmaceuticals recalled 14,923 bottles of Chlorpromazine Hydrochloride 100 mg tablets sold nationwide in the United States. A packaging coil used in the product’s packaging was found to contain a microorganism. No microorganism was detected on any tablets. Stop using the product and contact Amneal or your healthcare provider for guidance.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging 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 Amneal Pharmaceuticals, 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 in the United States through a network of healthcare providers.
A foreign microorganism was detected in packaging components made from auxiliary polyester coil. Tablets themselves were not shown to be contaminated. The risk comes from potential exposure to packaging-related contaminants.
This recall is not described as part of a broader industry pattern.
Consumers may need to switch medications under supervision. There is no reported contamination of tablets, but packaging contamination could pose health risks.
NDC and lot codes on label; recall notice provides official details.
Recall processing timelines are not specified in the notice.
Keep bottle, packaging, and recall notices. Save correspondence with the company and healthcare providers.
NDC: 69238-1060-1. Sold nationwide in the USA. 14,923 bottles recalled. Lot numbers AM240334, AM240335, AM241031. 100 mg tablets in 100-count bottles. Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, India. Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. Classification: Class II. Product type: Oral solid dosage unit (Tablets).
No injuries or incidents have been reported.
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