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Recall Observatory FDA recall evidence

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

March 27, 2018

Class II

Product summary

Firm
AuroMedics Pharma LLC
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

    reason.microbial_contamination · v1.0.0

    mold found
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility