AuroMedics Pharma LLC: Drug Recall
Recall #D-0248-2021 · 12/30/2020
Class II: Risk
Recall Details
- Recall Number
- D-0248-2021
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- AuroMedics Pharma LLC
- Status
- Terminated
- Date Initiated
- 12/30/2020
- Location
- East Windsor, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3094 cartons
Reason for Recall
Discoloration and failed pH specifications
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
Distribution Pattern
Nationwide
Other Recalls by AuroMedics Pharma LLC
- Class II: Risk 09/30/2022
- Class III: Low Risk 09/26/2022
- Class II: Risk 09/26/2022
- Class I: Dangerous 01/26/2022
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.