Caraco Pharmaceutical Laboratories, Ltd. recalls Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactu
Recalled July 2, 2014 · FDA recall D-1407-2014 · Caraco Pharmaceutical Laboratories
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. · FDA Class II
Units
200 vials
Sold at
OH
Description
Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.
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
Manufacturer(s)
Caraco Pharmaceutical Laboratories, Ltd.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →