Zydus Lifesciences Ltd. recalled Chlorpromazine Hydrochloride Tablets on September 3, 2025. The recall affects 10 mg tablets sold nationwide due to contamination with N-Nitroso Desmethyl Chlorpromazine. Consumers should stop using the product immediately and consult healthcare providers.
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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The recalled product is Chlorpromazine Hydrochloride Tablets, USP, 10 mg, sold in 100-count bottles. The affected lot numbers include Z403011 and Z407335 with expiration dates of April 30, 2026, and November 30, 2026, respectively.
The recall stems from CGMP deviations revealing N-Nitroso Desmethyl Chlorpromazine levels exceeding acceptable limits. This contamination poses serious health risks.
No specific incidents or injuries have been reported related to this recall. However, the contamination could lead to severe health implications.
Consumers and healthcare providers should stop using the product immediately. Contact Zydus Pharmaceuticals (USA) Inc for further guidance.
For assistance, contact Zydus Pharmaceuticals at [Contact Number Missing]. More details can be found at the FDA's website.
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