Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point.
Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing 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 Actavis South Atlantic LLC to request your refund or repair — edit it as you like.
Subject: Recall D-248-2013 — Actavis South Atlantic LLC Actavis South Atlantic LLC recalls buPROPion Hydrochloride Extended-Relea Hello, I own a Actavis South Atlantic LLC recalls buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-count tablets per bottle, Rx only, Distributed by: that is covered by recall D-248-2013 from Actavis South Atlantic LLC. 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.
