Zydus Lifesciences Ltd. recalled chlorpromazine hydrochloride tablets nationwide in the United States after tests found N-Nitroso Desmethyl Chlorpromazine above the acceptable intake limit. The issue involves CGMP deviations in manufacturing at the India facility and distribution by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ. Healthcare providers and patients should stop using the product, 0
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 certain psychiatric conditions. It is distributed as Rx-only tablets and requires medical supervision.
The recall centers on CGMP deviations that led to the detection of an impurity, N-Nitroso Desmethyl Chlorpromazine, above acceptable intake limits. Consumers should stop use immediately unless advised otherwise by a healthcare provider.
This recall is not described as part of a broader industry pattern in the notice.
Patients with the affected product may be exposed to higher impurity levels. There is an immediate safety concern, and providers should assess alternatives as needed.
NDC is printed on the bottle label; packaging and Rx labels list the model numbers and lot codes.
The recall notice does not specify a refund or replacement timeline.
Keep the recall notice, bottle label, and any correspondence with the manufacturer or healthcare providers. Photograph the label and store a digital copy of the notice.
Model numbers: Z306327, Z306748, Z401154, Z403738, Z405645. NDC: 70710-1131-1. Sold nationwide in the USA. Manufactured by Zydus Lifesciences Ltd., Baddi, India. Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. Rx only. Price: Unknown. Sold as 50 mg, 100-count bottles.
No injuries or incidents have been reported.
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