Drug recall D-0248-2021

Class II Terminated reported Feb 10, 2021

Product

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

Reason for recall

Discoloration and failed pH specifications

Lots and codes

CAT200002 exp 9/2022; CAT200004 exp 9/2022; CAT200005 exp 9/2022; CAT200008 exp 9/2022; CAT200009 exp 9/2022; CAT200013 exp 10/2022; CAT200014 exp 10/2022; CAT200015 exp 10/2022; CAT200016 exp 10/2022; CAT200017 exp 10/2022; CAT200018 exp 10/2022

Recall details

Recalling firm
AuroMedics Pharma LLC, East Windsor, NJ
Quantity
3094 cartons
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
December 30, 2020
Terminated
September 19, 2023

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