Drug product
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.
D-0705-2018
Product summary
- Event
- Event 79772
- Status
- Terminated
- Classification
- Class II
- Quantity
- 261250 bags
- Official record key
drug-enforcement:D-0705-2018
Official wording
Reason: Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Code information: Lot/Batch #'s: CLV160016, CLV160017, and CLV160018, exp Sept 2018, CLV160019, exp Oct 2018, CLV160020, CLV160021, and CLV160031, exp Nov 2018; CLV160032 and CLV170001, exp 12/18; CLV170008 and CLV170009, exp April 2019, CLV170020, CLV170021 and CLV170022, exp Oct 2019
Distribution pattern: US Nationwide
Derived failure modes
-
Microbial contamination
mold found
-
Sterility assurance
Lack of Assurance of Sterility