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Recall Observatory FDA recall evidence

Drug product

Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-248-47.

D-0707-2018

March 27, 2018

Class II

Product summary

Firm
AuroMedics Pharma LLC
Event
Event 79772
Status
Terminated
Classification
Class II
Quantity
67300 bags
Official record key
drug-enforcement:D-0707-2018

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: CLV160004, CLV160005, and CLV160006 exp September 2018; CLV170011, CLV170015, CLV170016 exp June 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