D-0248-2021 Class II Terminated
FDA drug recall D-0248-2021 was initiated by AuroMedics Pharma LLC on Dec 30, 2020 and is designated Class II. Reason for recall: Discoloration and failed pH specifications The recall status is terminated (terminated Sep 19, 2023). Affected quantity: 3094 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 10, 2021
- Initiation Date
- Dec 30, 2020
- Termination Date
- Sep 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0248-2021
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026