Drug 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
D-0574-2018
Product summary
- Event
- Event 78932
- Status
- Terminated
- Classification
- Class I
- Quantity
- 6,072 bags
- Official record key
drug-enforcement:D-0574-2018
Official wording
Reason: Presence of Particulate Matter; contains visible particulate matter identified as mold.
Code information: Lot CLF160003, exp May 2018
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter