Drug 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
D-0635-2024
Product summary
- Event
- Event 94934
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 31,400 bags
- Official record key
drug-enforcement:D-0635-2024
Official wording
Reason: 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)
Code information: Lot #24070381; Exp. 09/30/2025
Distribution pattern: OH and PR
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-up