FDA recall D-1407-2014

Product

Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd, Gujarat, India, NDC 47335-154-40

Reason for recall

Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.

Distribution

OH

Key facts

Status

Terminated

Initiation date

2014-04-09

Report date

2014-07-02

Termination date

2014-09-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Detroit, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1407-2014