FDA Recall Levetiracetam
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Levetiracetam with NDC 55150-246 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-0706-2018 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-0706-2018 | 03-27-2018 | 05-09-2018 | Class II | 188941 bags | Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-247-47. | Terminated |
D-0705-2018 | 03-27-2018 | 05-09-2018 | Class II | 261250 bags | Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-246-47. | Terminated |
D-0707-2018 | 03-27-2018 | 05-09-2018 | Class II | 67300 bags | Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-248-47. | 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.