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Recall Observatory FDA recall evidence

Drug 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

D-0248-2021

December 30, 2020

Class II

Product summary

Firm
AuroMedics Pharma LLC
Event
Event 87067
Status
Terminated
Classification
Class II
Quantity
3094 cartons
Official record key
drug-enforcement:D-0248-2021

Official wording

Reason: Discoloration and failed pH specifications

Code information: 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

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Discoloration and failed pH specifications