FDA-Drug2018-04-18Class III
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
InvaGen Pharmaceuticals, Inc.
Hazard
Failed impurities/degradation specifications: Failure to water content and impurity
Sold states
U.S.A. nationwide
Affected count
3222 vials
Manufactured in
550 S Research Pl, Central Islip, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0698-2018Don't want to check this manually?
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