Class II Terminated

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.

Company: Auromedics Pharma Llc
Recall Initiated: March 27, 2018
Posted: May 9, 2018
Recall Number: D-0706-2018
Voluntary / Mandated: Voluntary: Firm initiated
Quantity: 188941 bags
Firm Location: East Windsor, NJ, United States

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

Distribution

US Nationwide

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

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