Major Pharmaceuticals recalled 866 Chlorpromazine Hydrochloride 100 mg tablets distributed nationwide after CGMP deviations allowed N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit. The impurity detected raises safety concerns for ongoing use. Stop using the product immediately and contact Harvard Drug Group LLC dba Major Pharmaceuticals or Rugby Laboratories for guidance and,
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 to treat certain psychiatric conditions. The tablets are Rx-only and distributed nationwide.
N-nitroso impurities are potential carcinogens. The recall cites an impurity level above the recommended intake limit, prompting cessation of use.
This recall is not described as part of a broader industry pattern in the provided data.
Patients taking the medication may be affected nationwide. Immediate action is required to stop using the product and contact providers for guidance and refunds.
Packaging, patient information leaflets, and the FDA recall page for D-0012-2026.
Refund/replacement processing times are not specified in the recall notice.
Keep the recall notification, photos of packaging and labels, and records of all communications with the manufacturer or provider.
Brand: Major Pharmaceuticals. Product: Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100 tablets. Packaging: 100 tablets per blister, 10x10 blister packs. NDC: 0904-7132-61. UPC: (01)00309047132614. Quantity recalled: 866 blister packs. Sold/distributed: Nationwide. Rx status: Rx Only. Distributor/Manufacturer: The Harvard Drug Group LLC dba Major Pharmaceuticals; Rugby Laboratories; Major Pharmaceuticals, Indianapolis, IN 46268, USA. Recall date: 2025-09-12. Status: Active. Model numbers: N01920, N02023, N02202.
No injuries or incidents have been reported.
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