FDA Recall Levofloxacin
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Levofloxacin with NDC 55150-245 was initiated on 03-27-2018 as a Class II recall due to lack of assurance of sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap The latest recall number for this product is D-0708-2018 and the recall is currently terminated as of 02-18-2022 .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| D-0708-2018 | 03-27-2018 | 05-09-2018 | Class II | 308472 bags | 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 | Terminated |
| D-0709-2018 | 03-27-2018 | 05-09-2018 | Class II | 308112 bags | Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-245-52 | Terminated |
| D-0704-2018 | 03-27-2018 | 05-09-2018 | Class II | 46824 bags | 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. | Terminated |
| D-0574-2018 | 01-12-2018 | 03-07-2018 | Class I | 6,072 bags | 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 | Terminated |
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.