← FDA ENFORCEMENT
D-0635-2024Class I

Hikma Pharmaceuticals USA Inc.

Recalling firm
Hikma Pharmaceuticals USA Inc.
Product type
Drug
Status
Ongoing
Report date
2024-08-28
Distribution
OH and PR
Firm state
NJ
Product quantity
31,400 bags
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
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)

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

Code / lot info

Lot #24070381; Exp. 09/30/2025

Other recalls SPEQ maps to Documentation & Change Control
2026-07-22Class IIDaavlin Distributing Company2026-07-22Class ID'Dioses Fruit Pops, Inc.2026-07-22Class ID'Dioses Fruit Pops, Inc.2026-07-22Class IIChocolate Bar Holdings LLC
See all Documentation & Change Control recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.