Reported Feb 10, 2021 · Terminated

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

AuroMedics Pharma LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: AuroMedics Pharma LLC · 279 Princeton Hightstown Rd · East Windsor, NJ · 08520-1401

Is this the product you have?

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

11 of 11 products

Products covered by this recall
#Product as published
1CAT200002 exp 9/2022
2CAT200004 exp 9/2022
3CAT200005 exp 9/2022
4CAT200008 exp 9/2022
5CAT200009 exp 9/2022
6CAT200013 exp 10/2022
7CAT200014 exp 10/2022
8CAT200015 exp 10/2022
9CAT200016 exp 10/2022
10CAT200017 exp 10/2022
11CAT200018 exp 10/2022
Amount recalled
3094 cartons

Where it was sold

  • Nationwide

Why it was recalled

Discoloration and failed pH specifications

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 19, 2023 · Data as of Sep 19, 5:07 PM UTC

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