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
Product summary
- 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
Discoloration and failed pH specifications