CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
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 American Health Packaging to request your refund or repair — edit it as you like.
Subject: Recall D-1584-2019 — American Health Packaging American Health Packaging recalls Lovastatin Tablets USP, 40 mg, packaged Hello, I own a American Health Packaging recalls Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC that is covered by recall D-1584-2019 from American Health Packaging. 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.
