GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
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 Mylan Institutional, Inc. (d.b.a. UDL Laboratories) to request your refund or repair — edit it as you like.
Subject: Recall D-0823-2018 — Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Mylan Institutional, Inc. (d.b.a. UDL Laborator Hello, I own a Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. that is covered by recall D-0823-2018 from Mylan Institutional, Inc. (d.b.a. UDL Laboratories). 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.
