Major Pharmaceuticals recalled 2,064 blister packs of Chlorpromazine Hydrochloride Tablets, 25 mg, sold nationwide through healthcare providers. The recall follows CGMP deviations that allowed the presence of N-Nitroso Desmethyl Chlorpromazine above the allowed limit. Stop using the product immediately and await guidance from Major Pharmaceuticals or your healthcare provider.
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 medication used for certain psychiatric conditions and sometimes as an antiemetic in medical settings.
N-nitroso desmethyl chlorpromazine can pose health risks when present above the recommended limit due to CGMP deviations.
This recall is not described as part of a broader industry pattern in the provided data.
The recall affects patients and healthcare providers who rely on this medication; stopping use is advised and guidance will follow recall communications.
Recall notices and identifiers are listed in the FDA enforcement page linked in the recall notice.
Refunds or replacements, if offered, will follow the company's recall timeline communicated by letters.
Keep the packaging, recall notices, and records of any communications with the supplier.
Product: Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 50 tablets per blister pack (5x10). NDC: 0904-7130-06. UPC: (01)00309047130061. Quantity: 2064 blister packs. Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA. Sold nationwide to healthcare providers. Models: N01943, N02025. Recall date: 2025-09-12. Status: Active. Classification: Class II. Hazard: N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit. Remedy: Stop using the product and contact The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories for guidance. Country of origin:
No injuries or incidents have been reported.
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