cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure
cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure
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 Pharmaceuticals Inc. to request your refund or repair — edit it as you like.
Subject: Recall D-0819-2018 — Mylan Pharmaceuticals Inc. Mylan Pharmaceuticals Inc. recalls Amlodipine and Benazapril HCL Capsule Hello, I own a Mylan Pharmaceuticals Inc. recalls Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV that is covered by recall D-0819-2018 from Mylan Pharmaceuticals 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.
