RecallDepth
Class I Terminated

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.

Company
Mylan Institutional Llc
Recall Initiated
March 23, 2015
Posted
August 26, 2015
Recall Number
D-1334-2015
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
10,094 vials
Firm Location
Rockford, IL, United States

Reason for Recall

Presence of Particulate Matter

Distribution

Nationwide and Puerto Rico

Lot / Code Info

Lot #: 7801273, 7801284, Exp 05/16

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