AuroMedics Pharma LLC recalls Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, For Intravenous Use Only, Distributed…

Recall date

December 30, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0248-2021

FDA classification

Class II

Brand / firm

AuroMedics Pharma LLC

Sold / distributed

Nationwide

Why it was recalled

Discoloration and failed pH specifications

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

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