D-0704-2018 Class II Terminated
FDA drug recall D-0704-2018 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: 46824 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
- 46824 bags
Product Description
Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for: AuroMedics Pharma, LLC, NDC 55150-243-46.
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: CLF160002, CLF160004, CLF160005 exp May 2018; CLF160006, CLF160007 exp June 2018; CLF170027 exp July 2019; CLF170029 exp August 2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0704-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026