Major Pharmaceuticals recalled 1,394 blister packs of Chlorpromazine Hydrochloride Tablets, 200 mg, distributed nationwide. The recall cites CGMP deviations with the presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit. Healthcare providers and patients are urged to stop using the product and await guidance from Major Pharmaceuticals and Rugby Laboratories.
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 prescribed for certain psychiatric conditions. The recalled tablets were distributed nationwide in blister packs across the United States.
The recall centers on CGMP deviations due to the presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit detected in the product.
This recall is not described as part of a broader industry pattern in the provided notice.
Patients prescribed this drug may be affected if they possess the recalled lots. The immediate action is to stop use and contact the sponsor for guidance.
NDC 0904-7133-61 and UPC 0100309047133611 on the package
Refunds or replacements are handled per sponsor recall communications, typically within weeks to a few months following confirmation
Keep the recall notice, product packaging, and any correspondence with the sponsor. Record dates of purchase and prescription details if available.
Model numbers: N01928, N02008, N02071. Where sold: Nationwide. When sold: Unknown. Price: Unknown. NDC: 0904-7133-61. UPC: 0100309047133611. Quantity recalled: 1,394 blister packs.
No injuries or incidents have been reported.
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