Drug recall D-0704-2018
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.
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
Lots and codes
Lot/Batch #'s: CLF160002, CLF160004, CLF160005 exp May 2018; CLF160006, CLF160007 exp June 2018; CLF170027 exp July 2019; CLF170029 exp August 2019
Recall details
- Recalling firm
- AuroMedics Pharma LLC, East Windsor, NJ
- Quantity
- 46824 bags
- Distribution
- US Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 27, 2018
- Terminated
- February 18, 2022
Related products
- Levofloxacin – drug information
- NDC 55150-243 Levofloxacin · Levofloxacin 250 mg/50mL · Eugia US LLC
- NDC 55150-245 Levofloxacin · Levofloxacin 750 mg/150mL · Eugia US LLC
- NDC 55150-244 Levofloxacin · Levofloxacin 500 mg/100mL · Eugia US LLC