Major Pharmaceuticals recalled 866 blister packs of Chlorpromazine Hydrochloride Tablets on September 12, 2025. The recall follows the detection of N-Nitroso Desmethyl Chlorpromazine above safe limits. The affected products were distributed nationwide and are classified as a Class II hazard.
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Consumers and healthcare providers should stop using this product immediately. Contact The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories or your healthcare provider for guidance. Notification method: Letter
The recall affects Chlorpromazine Hydrochloride Tablets, USP, 100 mg, packaged in 100 tablets per blister pack. The recalled lots include N01920, N02023, and N02202, with expiration dates of December 31, 2025, February 28, 2026, and June 30, 2026 respectively. The products were distributed nationwide.
The recall stems from CGMP deviations, specifically the presence of N-Nitroso Desmethyl Chlorpromazine at levels above the recommended intake limit. This contaminant poses potential health risks to consumers.
No specific incidents of injury or illness linked to this product have been reported at this time. The hazard level is classified as high due to the potential health implications associated with the contaminant.
Consumers and healthcare providers should stop using the recalled product immediately. Contact The Harvard Drug Group LLC or your healthcare provider for further guidance.
For questions, consumers can reach The Harvard Drug Group LLC at their website or by contacting their customer service.
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