InvaGen Pharmaceuticals, Inc. recalls Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla
Recalled April 18, 2018 · FDA recall D-0698-2018 · InvaGen Pharmaceuticals
Hazard
Failed impurities/degradation specifications: Failure to water content and impurity · FDA Class III
Units
3222 vials
Sold at
U.S.A. nationwide
Description
Failed impurities/degradation specifications: Failure to water content and impurity
Product
Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-285-37
Manufacturer(s)
InvaGen Pharmaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →