Class IOngoing

Acetaminophen Injection recall

FDA recall D-0635-2024 · initiated Jul 8, 2024

Most serious — a reasonable probability that use will cause serious harm or death.

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)

Details

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
Recalling company: Hikma Intl Pharms
Classification: Class I
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: OH and PR
Initiated: Jul 8, 2024
FDA report date: Aug 28, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0635-2024 ↗

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