Drug product
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.
D-0706-2018
Product summary
- Event
- Event 79772
- Status
- Terminated
- Classification
- Class II
- Quantity
- 188941 bags
- Official record key
drug-enforcement:D-0706-2018
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: CLV160013, CLV160014 and CLV160015, exp Sept 2018; CLV160022, CLV160023, CLV160024, CLV160025, CLV160026, CLV160027, CLV160028, CLV160029, CLV160030 exp Oct 2018; CLV170002, Dec 2018; CLV170010, exp April 2019; CLV170027, CLV170028, CLV170029 and CLV170030 exp Oct 2019
Distribution pattern: US Nationwide
Derived failure modes
-
Microbial contamination
mold found
-
Sterility assurance
Lack of Assurance of Sterility