D-0248-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 10, 2021
- Initiation Date
- December 30, 2020
- Termination Date
- September 19, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3094 cartons
Product 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
Reason for Recall
Discoloration and failed pH specifications
Distribution Pattern
Nationwide
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