Recalls / Class I
Class ID-0635-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Brand name
- Acetaminophen
- Generic name
- Acetaminophen
- Active ingredient
- Acetaminophen
- Route
- Intravenous
- NDC
- 0143-9386
- FDA application
- NDA206968
- Affected lot / code info
- Lot #24070381; Exp. 09/30/2025
Why it was recalled
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)
Recalling firm
- Firm
- Hikma Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Esterbrook Ln, Cherry Hill, New Jersey 08003-4002
Distribution
- Quantity
- 31,400 bags
- Distribution pattern
- OH and PR
Timeline
- Recall initiated
- 2024-07-08
- FDA classified
- 2024-08-16
- Posted by FDA
- 2024-08-28
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0635-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.