CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
We’ve drafted a message you can send MACLEODS PHARMA USA, INC to request your refund or repair — edit it as you like.
Subject: Recall D-1459-2019 — MACLEODS PHARMA USA, INC Macleods Pharma Usa Inc recalls Losartan Potassium and Hydrochlorothiazide Hello, I own a Macleods Pharma Usa Inc recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma that is covered by recall D-1459-2019 from MACLEODS PHARMA USA, INC. 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.
