FDA recall D-1333-2015

Product

Gemcitabine for Injection, USP, 2 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-463-02, UPC 3 67457 46302 5.

Reason for recall

Presence of Particulate Matter

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2015-03-23

Report date

2015-08-26

Termination date

2016-05-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rockford, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1333-2015