FDA-Drug2014-07-02Class II
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
Caraco Pharmaceutical Laboratories, Ltd.
Hazard
Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.
Sold states
OH
Affected count
200 vials
Manufactured in
1150 Elijah McCoy Dr, N/A, Detroit, MI, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1407-2014Don't want to check this manually?
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