Recalls / Class II
Class IID-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
- Brand name
- Levofloxacin
- Generic name
- Levofloxacin In 5% Dextrose
- Active ingredient
- Levofloxacin
- Route
- Intravenous
- NDCs
- 55150-243, 55150-244, 55150-245
- FDA application
- ANDA206919
- Affected lot / code info
- 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
Why it was recalled
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Recalling firm
- Firm
- AuroMedics Pharma LLC
- Manufacturer
- Eugia US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 308472 bags
- Distribution pattern
- US Nationwide
Timeline
- Recall initiated
- 2018-03-27
- FDA classified
- 2018-05-03
- Posted by FDA
- 2018-05-09
- Terminated
- 2022-02-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0708-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.