cGMP Deviations: lack of quality assurance at the API manufacturer.
cGMP Deviations: lack of quality assurance at the API manufacturer.
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 Fagron, Inc to request your refund or repair — edit it as you like.
Subject: Recall D-0079-2018 — Fagron, Inc Fagron, Inc recalls Estriol, For Prescription Compounding, packaged in a) 1 G bottle (N Hello, I own a Fagron, Inc recalls Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: that is covered by recall D-0079-2018 from Fagron, 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.
