CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
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 Amerisource Health Services LLC to request your refund or repair — edit it as you like.
Subject: Recall D-0158-2025 — Amerisource Health Services LLC Amerisource Health Services LLC recalls Duloxetine Delayed-Release Hello, I own a Amerisource Health Services LLC recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma that is covered by recall D-0158-2025 from Amerisource Health Services LLC. 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.
