Drug recall D-0337-2018

Class I Terminated reported Feb 14, 2018

Product

Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap, Rx only, Mfd in India for: AuroMedics Pharma LLC, Dayton, NJ --- NDC 55150-242-51

Reason for recall

Presence of Particulate Matter; white particulate matter identified as mold was found in one bag

Lots and codes

Lot # CLZ160007, Exp August 2018

Recall details

Recalling firm
AuroMedics Pharma LLC, East Windsor, NJ
Quantity
9,050 bags
Distribution
Product was distributed throughout United States.
Type
Voluntary: Firm initiated
Recall initiated
December 20, 2017
Terminated
June 24, 2019

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