Drug FDA Class I Ongoing Mislabeling

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

Hikma Pharmaceuticals USA Inc. Published Aug 28, 2024

Risk level

Class I

Dangerous or defective — could cause serious health problems or death.

Severity score 75/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Hikma Pharmaceuticals USA Inc. or your place of purchase with questions, and see the source record below for full details.

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)

Affected products (1)

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

ACETAMINOPHEN · 31,400 bags

NDC: 0143-9386, 0143-9386-01, 0143-9386-10

Lot codes: 24070381

Code info: Lot #24070381; Exp. 09/30/2025

Affected areas

OhioPuerto Rico

Timeline

Initiated

Jul 8, 2024
Published

Aug 28, 2024

Recall number: D-0635-2024
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.