FDAFDA · Food and drugs·Recall number D-0635-2024
Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica (Portugal), SA, distributed by Hikma Pharmaceuticals USA Inc Berkeley Heights, NJ NDC 0143-9386-01
Published August 28, 2024 · Recall initiated: July 8, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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)
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ACETAMINOPHEN
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Distributor
- OH and PR
- Lot
- Lot #24070381; Exp. 09/30/2025
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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