FDA recall D-0698-2018

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

Reason for recall

Failed impurities/degradation specifications: Failure to water content and impurity

Distribution

U.S.A. nationwide

Key facts

Status

Terminated

Initiation date

2018-03-05

Report date

2018-04-18

Termination date

2021-01-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Central Islip, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0698-2018