Major Pharmaceuticals, via The Harvard Drug Group LLC, recalled 506 blister packs of Chlorpromazine Hydrochloride tablets, 50 mg, distributed nationwide. A CGMP deviation shows the presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit. Stop using the product and contact the Harvard Drug Group or Rugby Laboratories for guidance.
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
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Chlorpromazine hydrochloride is a prescription antipsychotic used for certain psychiatric conditions. The recalled lots were packaged as 50 mg tablets in 10x10 blister packs and distributed nationwide.
The impurity N-Nitroso Desmethyl Chlorpromazine was found above the recommended intake limit due to CGMP deviations in manufacturing. Prolonged exposure to nitrosamine impurities can pose health risks.
This recall is not part of a broader industry pattern.
Consumers prescribed this drug should stop using the affected lots and contact their healthcare provider. The recall covers 506 blister packs nationwide and may affect patients who rely on this medication for treatment.
FDA enforcement page for recall D-0011-2026 and the distributor’s recall notice.
Refunds or replacements, if offered, typically take 4-8 weeks.
Retain the product packaging, recall notice, and any correspondence with the distributor and your healthcare provider for records.
Model numbers: N02009, N02026. NDC: 0904-7131-61. UPC: (01)00309047131617. Quantity: 506 blister packs. Distribution: Nationwide. Sold at: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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