Major Pharmaceuticals recalled 1,256 blister packs of Chlorpromazine Hydrochloride tablets, 25 mg, sold nationwide in the United States. A CGMP deviation led to the presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake. Healthcare providers and patients should stop using the product and contact Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories for next-步
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 an antipsychotic used to treat certain mental health conditions. This recall pertains to a specific batch of 25 mg tablets packaged as 100 per blister.
Nitrosamines are potential carcinogens. The recall cites CGMP deviations that allowed N-Nitroso Desmethyl Chlorpromazine above the recommended intake.
This recall is not described as part of a broader industry pattern.
Patients taking this medication should stop using it and consult their healthcare provider. The recall could prompt changes in medication regimens and require medical supervision.
FDA recall page linked above and recall letters from Major Pharmaceuticals and Rugby Laboratories
Refunds or replacements typically processed after recall verification; estimate 4-8 weeks
Keep the recall letter, packaging photographs, receipts, and all communications with healthcare providers or pharmacies
Model numbers: N01954, N02024. Sold nationwide in blister packs containing 100 tablets (10x10) per pack. NDC 0904-7130-61. UPC 01 00309047130610. Pack size: 1256 blister packs. Category: Prescription drug. Sold by The Harvard Drug Group LLC dba Major Pharmaceuticals; distributed in the United States.
No injuries or incidents have been reported.
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