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

Class I - Dangerous
💊 Drugs Recalled: December 30, 2020 AuroMedics Pharma Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
AuroMedics Pharma LLC
Reason for Recall:
Discoloration and failed pH specifications
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0248-2021

Related Recalls