Class I
Ongoing
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
This recall is currently active, issued August 28, 2024. It was issued by Hikma Pharmaceuticals Usa Inc..
- Company
- Hikma Pharmaceuticals Usa Inc.
- Recall Initiated
- July 8, 2024
- Posted
- August 28, 2024
- Recall Number
- D-0635-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 31,400 bags
- Firm Location
- Cherry Hill, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
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)
Distribution
OH and PR
Lot / Code Info
Lot #24070381; Exp. 09/30/2025
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