CLASS II Drug recall · Reported 10 Feb 2021 · FDA Enforcement Report

Acetaminophen Injection 1,000 mg recalled by AuroMedics Pharma

AuroMedics Pharma is recalling Acetaminophen Injection 1,000 mg per (10 mg/mL) Single Dose Vial, For Intravenous Use Only, distributed nationwide in the US. The recall was initiated on 30 Dec 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCAT200002 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

NDC55150-307

UPC0355150307012

Quantity recalled3094 cartons

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0248-2021
FDA event ID: 87067
Recalling firm: AuroMedics Pharma, East Windsor, NJ
Brand: Acetaminophen
Manufacturer: Eugia US LLC
Classification: Class II
Status: Terminated
Recall initiated: 30 Dec 2020
FDA classified: 4 Feb 2021
Reported: 10 Feb 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Drug class: Pain Medication

Timeline

30 Dec 2020	Recall initiated by company
4 Feb 2021	Classified by FDA	+36 days
10 Feb 2021	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Discoloration and failed pH specifications

Product as listed by the FDA

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

Where it was distributed

Nationwide

Questions about this recall

Is Acetaminophen Injection 1,000 mg per (10 mg/mL) Single Dose Vial, For Intravenous Use Only recalled?

Yes. AuroMedics Pharma recalled Acetaminophen Injection 1,000 mg per (10 mg/mL) Single Dose Vial, For Intravenous Use Only on 30 Dec 2020. The recall is Class II and its status is Terminated. Recall number D-0248-2021.

Why was it recalled?

Discoloration and failed pH specifications

Which lots are affected?

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

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from AuroMedics Pharma

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28 Aug 2024Drug	CLASS I	Acetaminophen Injection, 1,000 mg recalled by Hikma Pharmaceuticals USAAcetaminophen	Hikma Pharmaceuticals USA	Packaging Defects	OH, PR
14 Aug 2024Drug	CLASS I	Acetaminophen Extra Strength Tablets, 500 mg each recalledAcetaminophen	A-S Medication Solutions	Labeling Errors	Nationwide