Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.
Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.
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 Amedra Pharmaceuticals LLC to request your refund or repair — edit it as you like.
Subject: Recall D-385-2014 — Amedra Pharmaceuticals LLC Amedra Pharmaceuticals LLC recalls Dexedrine¿ (Dextroamphetamine Sulfate) Hello, I own a Amedra Pharmaceuticals LLC recalls Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15mg, 90 count bottle, Rx only, that is covered by recall D-385-2014 from Amedra Pharmaceuticals 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.