Major Pharmaceuticals recalls 10mg ChlorproMAZINE Hydrochloride Tablets with N-Nitroso-Desmethyl Chlorpromazine impurity above safety limits. Rx-only medication distributed in cartons of 100 tablets.
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Major Pharmaceuticals is recalling 10mg ChlorproMAZINE Hydrochloride Tablets because they contain an impurity that exceeds safety limits. This could pose a health risk if taken as directed.
The tablets contain N-Nitroso-Desmethyl Chlorpromazine impurity levels above the recommended safety limit. This impurity could potentially cause health issues when taken as prescribed.
People who have prescription ChlorproMAZINE Hydrochloride Tablets from Major Pharmaceuticals. Those with medical conditions requiring this medication are most at risk.
Check for 10mg ChlorproMAZINE Hydrochloride Tablets in cartons of 100 tablets (10x10). The product was distributed by Major Pharmaceuticals with NDC 0904-7129-61 and Lot# N02114.
Look for the product name, dosage, and packaging details to confirm if it matches the recalled items.
The recall indicates the tablets contain an impurity above safety limits, so they are not safe to take as prescribed.
Check for 10mg ChlorproMAZINE Hydrochloride Tablets in cartons of 100 tablets (10x10) with NDC 0904-7129-61 and Lot# N02114.
The recall does not specify a remedy, so contact the manufacturer for guidance.
We’ve drafted a message you can send Major Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0366-2025 — Major Pharmaceuticals Major Pharmaceuticals Hello, I own a Major Pharmaceuticals that is covered by recall D-0366-2025 from Major Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
