Recalls / Class II
Class IID-0706-2018
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.
- 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: 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
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
- 188941 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-0706-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.