Major Pharmaceuticals announced a recall of 1,256 blister packs of Chlorpromazine Hydrochloride Tablets on September 12, 2025. The recall stems from the presence of N-Nitroso Desmethyl Chlorpromazine above safe intake levels. Consumers must stop using the product immediately and contact their healthcare provider 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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The recalled product is Chlorpromazine Hydrochloride Tablets, USP, 25 mg, packaged in 100 tablets (10x10 blister package). The recall involves lots N01954 (Exp. 11/30/2025) and N02024 (Exp. 02/28/2026). This medication was distributed nationwide.
The recall addresses CGMP deviations due to the presence of N-Nitroso Desmethyl Chlorpromazine, which exceeds the recommended intake limit. This contaminant poses a significant health risk.
No specific incidents or injuries related to this recall have been reported. The presence of harmful contaminants warrants immediate action.
Consumers and healthcare providers should stop using the recalled tablets immediately. Contact The Harvard Drug Group LLC or your healthcare provider for further guidance.
For questions regarding the recall, call Major Pharmaceuticals at 1-800-XXX-XXXX. More information is available at the FDA's website.
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