D-0707-2018 Class II Terminated
FDA drug recall D-0707-2018 was initiated by AuroMedics Pharma LLC on Mar 27, 2018 and is designated Class II. Reason for recall: Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap The recall status is terminated (terminated Feb 18, 2022). Affected quantity: 67300 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- May 9, 2018
- Initiation Date
- Mar 27, 2018
- Termination Date
- Feb 18, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 67300 bags
Product Description
Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-248-47.
Reason for Recall
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Distribution Pattern
US Nationwide
Code Information
Lot/Batch #'s: CLV160004, CLV160005, and CLV160006 exp September 2018; CLV170011, CLV170015, CLV170016 exp June 2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0707-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026