Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
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 Hikma Pharmaceuticals USA INC to request your refund or repair — edit it as you like.
Subject: Recall D-1533-2020 — Hikma Pharmaceuticals USA INC Hikma Pharmaceuticals USA Inc. recalls Buprenorphine HCl Injection, 0 Hello, I own a Hikma Pharmaceuticals USA Inc. recalls Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, Manufactured by: that is covered by recall D-1533-2020 from Hikma Pharmaceuticals USA 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.
