Drug recall D-0708-2018
Product
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
Lots and codes
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
Recall details
- Recalling firm
- AuroMedics Pharma LLC, East Windsor, NJ
- Quantity
- 308472 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