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-0706-201803-27-201805-09-2018Class II188941 bagsLevetiracetam 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-0705-201803-27-201805-09-2018Class II261250 bagsLevetiracetam 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-0707-201803-27-201805-09-2018Class II67300 bagsLevetiracetam 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.