Zydus Lifesciences and Northstar Rx LLC recall Chlorpromazine Hydrochloride Tablets, 50 mg, 100-count bottles distributed nationwide in the United States. The recall cites CGMP deviations and the presence of N-Nitroso Desmethyl Chlorpromazine above the acceptable intake limit. Stop using the product immediately and contact your healthcare provider or Zydus Pharmaceuticals (USA) Inc 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 a prescription antipsychotic used to treat certain mental disorders. This recall involves a 50 mg, 100-count bottle intended for Rx use.
The recall cites CGMP deviations resulting in the impurity N-Nitroso Desmethyl Chlorpromazine exceeding acceptable intake limits.
This recall is not described as part of a broader industry pattern in the provided information.
Exposure to the impurity could pose long-term health risks. There are no reported injuries or incidents yet. Consumers should stop use and seek guidance from a healthcare provider.
NDC on the bottle label and packaging; recall page on FDA site
Refunds or replacements will be determined by the manufacturer; monitor updates from FDA and company communications (no specific timeframe provided)
Retain the bottle, packaging, recall notification, and any communications with the manufacturer or healthcare provider
Model numbers: Z306326; Z401155 Where sold: Nationwide in the USA When sold: N/A Price: N/A
No injuries or incidents have been reported.
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