US Drug Recall Register
Class II · Moderate risk Terminated Initiated Dec 30, 2020 (6 years ago)

Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, For…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Discoloration and failed pH specifications

What was recalled

Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, For Intravenous Use Only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Made in India NDC 55150-307-01

Recalling firm
AuroMedics Pharma LLC
NDC code
55150-307-01
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0248-2021

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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