Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point
Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month 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 Shionogi Inc. to request your refund or repair — edit it as you like.
Subject: Recall D-1398-2012 — Shionogi Inc. Shionogi Inc. recalls Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, R Hello, I own a Shionogi Inc. recalls Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured for: Prasco Laboratories Mason OH that is covered by recall D-1398-2012 from Shionogi 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.