Class II · Moderate risk Ongoing
Decitabine for Injection 50mg per vial
Reason CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Decitabine for Injection
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed impurities/degradation specifications: Failure to water content and impurity
What was recalled
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
- Recalling firm
- InvaGen Pharmaceuticals, Inc.
- NDC code
- 69097-285-37
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0698-2018
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Decitabine recalls
See all
Class II · Moderate risk Terminated
DECITABINE 40 MG / 100 ml NS IVPB
Reason Lack of Assurance of Sterility
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