The FDA confirms a nationwide recall of Zydus Lifesciences Chlorpromazine Hydrochloride tablets 200 mg (NDC 70710-1133-1) distributed by Zydus Pharmaceuticals USA. The recall cites CGMP deviations and the presence of N-Nitroso Desmethyl Chlorpromazine above acceptable intake. Consumers and healthcare providers should stop using the product immediately and contact the distributor 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 is an antipsychotic medication used to treat manic depression and schizophrenia symptoms.
The impurity N-Nitroso Desmethyl Chlorpromazine above acceptable intake could pose health risks; CGMP deviations indicate manufacturing quality concerns.
This recall is not part of a broader pattern in the industry.
No injuries reported yet. The recall focuses on product safety and potential long-term health risks.
FDA recall page and manufacturer contact; packaging details on label
No timeline provided; monitor FDA updates
Keep bottle, packaging, recall notice, and correspondence with supplier
Brand: Chlorpromazine Hydrochloride. Manufacturer: Zydus Lifesciences Ltd., Baddi, India. Distributor: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1133-1. Quantity and packaging: 100-count bottle. Sold nationwide in the USA. Recall date: 2025-09-03. Status: Active.
No specific consumer injuries or incidents are reported in the notice.
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