Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol.
Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol.
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-0801-2020 — Hikma Pharmaceuticals USA INC Hikma Pharmaceuticals USA Inc. recalls methylPREDNISolone Sodium Succ Hello, I own a Hikma Pharmaceuticals USA Inc. recalls methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), that is covered by recall D-0801-2020 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.
