Recalls / Class II
Class IID-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.
- Brand name
- Levetiracetam
- Generic name
- Levetiracetam In Sodium Chloride
- Active ingredient
- Levetiracetam
- Route
- Intravenous
- NDCs
- 55150-246, 55150-247, 55150-248
- FDA application
- ANDA207160
- Affected lot / code info
- 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
Why it was recalled
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Recalling firm
- Firm
- AuroMedics Pharma LLC
- Manufacturer
- Eugia US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 261250 bags
- Distribution pattern
- US Nationwide
Timeline
- Recall initiated
- 2018-03-27
- FDA classified
- 2018-05-03
- Posted by FDA
- 2018-05-09
- Terminated
- 2022-02-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0705-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.