D-0708-2018 Class II Terminated
FDA drug recall D-0708-2018 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: 308472 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
- 308472 bags
Product Description
Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-244-47
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: CLF160008, CLF160009, CLF160010, CLF160011, exp June 2018; CLF160015, CLF160016 , CLF160017, exp August 2018; CLF170001 exp December 2018; CLF170023, CLF170024, exp May 2019; CLF170039, CLF170040, CLF170041, CLF170042, CLF170043, CLF170044, CLF170045, CLF170046, CLF170047 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-0708-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026