Recalls / Class III
Class IIID-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
- Affected lot / code info
- Lot #: GE70493, GE70502, GE70512, Exp 8/2019
Why it was recalled
Failed impurities/degradation specifications: Failure to water content and impurity
Recalling firm
- Firm
- InvaGen Pharmaceuticals, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 550 S Research Pl, Central Islip, New York 11722-4415
Distribution
- Quantity
- 3222 vials
- Distribution pattern
- U.S.A. nationwide
Timeline
- Recall initiated
- 2018-03-05
- FDA classified
- 2018-04-26
- Posted by FDA
- 2018-04-18
- Terminated
- 2021-01-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0698-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.