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Class I · Most seriousActive recall

Acetaminophen

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLot #24070381; Exp. 09/30/2025
Where it was soldOH and PR
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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)

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byHikma Farmaceutica (Portugal), SA, distributed by Hikma Pharmaceuticals USA Inc Berkeley Heights, NJ
Brand nameACETAMINOPHEN
Generic nameACETAMINOPHEN
Active ingredient(s)ACETAMINOPHEN
Distributed by / forHikma Pharmaceuticals USA Inc Berkeley Heights, NJ
NDC0143-9386-01
Show the full FDA record
Full product labelAcetaminophen 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
Recalling firmHikma Pharmaceuticals USA Inc.
DistributionOH and PR
Quantity31,400 bags
Recall initiated2024-07-08
Report date2024-08-28
Recall completed—
Recall numberD-0635-2024
ClassificationClass I
FDA statusOngoing
Origin on fileCherry Hill NJ United States

Related

Acetaminophen recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.