Drug product
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.
D-0704-2018
Product summary
- Event
- Event 79772
- Status
- Terminated
- Classification
- Class II
- Quantity
- 46824 bags
- Official record key
drug-enforcement:D-0704-2018
Official wording
Reason: Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Code information: Lot/Batch #'s: CLF160002, CLF160004, CLF160005 exp May 2018; CLF160006, CLF160007 exp June 2018; CLF170027 exp July 2019; CLF170029 exp August 2019
Distribution pattern: US Nationwide
Derived failure modes
-
Microbial contamination
mold found
-
Sterility assurance
Lack of Assurance of Sterility