July 2024 FDA Recall Acetaminophen by Hikma Pharmaceuticals Usa Inc.
D-0635-2024 - Labeling
This Class I drug recall was voluntarily initiated by Hikma Pharmaceuticals Usa Inc. on July 8, 2024 for the product Acetaminophen. The FDA reported the reason for recall as labeling. The product was distributed in OH and PR and the recall is currently ongoing.
Recall Number: 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)
07-08-2024
08-28-2024
31,400 bags
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hikma Pharmaceuticals USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
OH and PR
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# 24070381; Exp. 09/30/2025
