FDAHealthJuly 8, 2024
Hikma Pharmaceuticals USA Inc. — 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
⚠️ 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)
Is this relevant to me?
- Geography
- OH, PR
- Source agency
- FDA
- Category
- Health
- Published
- July 8, 2024
OH and PR
What's affected?
- Product
- 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
- Brand
- ACETAMINOPHEN
- Lot code
- 24070381
Additional details
Lot #24070381; Exp. 09/30/2025
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 31,400 bags.
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