Drug recall D-0574-2018
Product
Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container, Rx Only, Manufactured for: AuroMedics Pharma LLC 6 Wheeling Drive, Dayton, NJ 08810 Manufactured for: Aurobindo Pharma Limited IDA, Pashamylaram - 502307, India ---- NDC 55150-243-46
Reason for recall
Presence of Particulate Matter; contains visible particulate matter identified as mold.
Lots and codes
Lot CLF160003, exp May 2018
Recall details
- Recalling firm
- AuroMedics Pharma LLC, East Windsor, NJ
- Quantity
- 6,072 bags
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 12, 2018
- Terminated
- April 1, 2020
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