Drug recall D-0705-2018
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.
Reason for recall
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Lots and codes
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
Recall details
- Recalling firm
- AuroMedics Pharma LLC, East Windsor, NJ
- Quantity
- 261250 bags
- Distribution
- US Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 27, 2018
- Terminated
- February 18, 2022
Related products
- Levetiracetam – drug information
- NDC 55150-247 Levetiracetam · Levetiracetam 1000 mg/100mL · Eugia US LLC
- NDC 55150-248 Levetiracetam · Levetiracetam 1500 mg/100mL · Eugia US LLC
- NDC 55150-246 Levetiracetam · Levetiracetam 500 mg/100mL · Eugia US LLC