Drug recall D-0574-2020

Class II Terminated reported Dec 18, 2019

Product

Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft. in India for: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-204-20.

Reason for recall

Discoloration: Product complaints of discoloration after reconstitution of vials.

Lots and codes

Lot #: CVM180003, CVM180004, Exp 04/2020; CVM180008, Exp 07/2020; CVM180009, CVM180010, CVM180011, CVM180012, Exp 09/2020

Recall details

Recalling firm
AuroMedics Pharma LLC, East Windsor, NJ
Quantity
275,060 vials
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
November 25, 2019
Terminated
March 4, 2021

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