Drug recall D-1334-2015

Class I Terminated reported Aug 26, 2015

Product

Gemcitabine for Injection, USP, 1 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-462-01, UPC 3 67457 46201 1.

Reason for recall

Presence of Particulate Matter

Lots and codes

Lot #: 7801273, 7801284, Exp 05/16

Recall details

Recalling firm
Mylan Institutional LLC, Rockford, IL
Quantity
10,094 vials
Distribution
Nationwide and Puerto Rico
Type
Voluntary: Firm initiated
Recall initiated
March 23, 2015
Terminated
May 20, 2016