Zydus Lifesciences Chlorpromazine Hydrochloride Tablets, 100 mg, 100-count bottles distributed nationwide in the USA for Northstar Rx LLC, Memphis, TN 38141, are recalled. The recall cites CGMP deviations with the presence of N-Nitroso Desmethyl Chlorpromazine above the acceptable intake. Healthcare providers and patients should stop using the product immediately and contact the manufacturer or a医
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 is an antipsychotic used to treat schizophrenia and other psychiatric conditions. It is a prescription medication in the United States. The recalled product was manufactured in India for Northstar Rx LLC.
The hazard arises from CGMP deviations leading to nitrosamine impurity exposure. Nitrosamines have been linked to cancer risk with long-term exposure.
This recall is not described as part of a broader industry pattern in the provided data.
If exposed to the impurity, patients may face potential cancer risk. Immediate cessation of use is advised and medical guidance should be sought.
FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0637-2025
Not specified in the recall notice.
Keep the recall notice, bottle label, NDC, and lot numbers. Document communications with healthcare providers and manufacturers.
Product: Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle (Rx only). Manufacturer: Zydus Lifesciences Ltd., Baddi, India. Manufactured for: Northstar Rx LLC, Memphis, TN 38141. NDC: 16714-050-01. Lot numbers: Z305456; Z401156; Z407306. Sold nationwide in the USA. Recall date: 2025-09-03. Status: Active. Hazard level: HIGH. Price: Unknown.
No injuries or incidents have been reported.
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