Zydus Lifesciences and Northstar Rx LLC recall Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottles nationwide in the United States. The recall cites CGMP deviations and the presence of N-nitroso desmethyl chlorpromazine above acceptable intake limits. Consumers should stop using the product and contact the manufacturer or a healthcare provider for guidance.
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Consumers and healthcare providers should stop using this product immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for guidance. Notification method: N/A
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Chlorpromazine hydrochloride tablets are an older antipsychotic medication used to treat certain psychiatric conditions. They are prescription-only and distributed through healthcare channels.
The CGMP deviation allowed nitrosamine impurities at levels above acceptable intake. Nitrosamines can pose cancer risks with long-term exposure.
This recall is not part of a broader industry pattern.
Patients may need to switch medications under clinician guidance. Stored or dispensed lots may be recalled from pharmacies.
NDC on packaging; recall notice on FDA enforcement page and manufacturer communications
Refund or replacement processing typically 4-8 weeks after submission of required information
Keep packaging, receipts, and correspondence; photograph bottle and label for records
Model numbers: Z305062, Z306324, Z401151, Z401152; NDC 16714-048-01; 25 mg, 100-count RX bottles; Rx only; Manufactured by Zydus Lifesciences Ltd., Baddi, India; Manufactured for Northstar Rx LLC, Memphis, TN 38141; Distribution: Nationwide in the USA.
No injuries or incidents have been reported.
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