Status
Ongoing
Drug Enforcement D-0635-2024
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)
Classification
Class I
Report Date
August 28, 2024
Termination Date
—
Product Information
- Product description
- 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
- Product quantity
- 31,400 bags
- 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)
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- OH and PR
Location & Firm
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
- Address
-
2 Esterbrook Ln
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0635-2024
- Event ID
- 94934
- Recall initiation date
- July 8, 2024
- Center classification date
- August 16, 2024
- Code info
- Lot #24070381; Exp. 09/30/2025
- More code info
- —