Hikma Pharmaceuticals recalls acetaminophen injection due to label mix-up with dexmedetomidine. This could lead to incorrect medication use. Check your product details and contact Hikma for guidance.
Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)
Hikma Pharmaceuticals is recalling acetaminophen injection products because they were mistakenly labeled with dexmedetomidine. This mix-up could cause someone to use the wrong medication, which is dangerous for intravenous use.
The label mix-up means that a bag of dexmedetomidine HCl injection was found inside an overwrap labeled as acetaminophen injection. This could lead to using the wrong medication, which is dangerous for intravenous administration.
Healthcare professionals who use these injections for medical treatment are most at risk. Patients receiving intravenous acetaminophen under a doctor's prescription may also be affected.
Check for the product name 'Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL)' on the label. The product was manufactured by Hikma Farmaceutica (Portugal) and distributed by Hikma Pharmaceuticals USA Inc. in the US.
Look for the label that says 'Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL)' on the overwrap.
No, the label mix-up means this product could be used incorrectly, which is dangerous for intravenous use.
Check for the product name 'Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL)' on the label, manufactured by Hikma Farmaceutica (Portugal).
The recall record does not specify a remedy, so contact Hikma Pharmaceuticals for guidance.
We’ve drafted a message you can send Hikma Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0635-2024 — Hikma Pharmaceuticals Hikma Pharmaceuticals Hello, I own a Hikma Pharmaceuticals that is covered by recall D-0635-2024 from Hikma Pharmaceuticals. 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.
