Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.
Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.
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 Boehringer Ingelheim Roxane Inc to request your refund or repair — edit it as you like.
Subject: Recall D-1085-2015 — Boehringer Ingelheim Roxane Inc Boehringer Ingelheim Roxane Inc recalls Acarbose Tablets 50 mg a)10 Hello, I own a Boehringer Ingelheim Roxane Inc recalls Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, Roxane Laboratories, that is covered by recall D-1085-2015 from Boehringer Ingelheim Roxane 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.
