FDA Drug recall D-0698-2018
Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sa…
- FDA Drug
- Class III
- terminated
- Published 2018-04-18
On 2018-04-18 the FDA classified a Class III recall of Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sa… by Invagen Pharmaceuticals, citing failed impurities/degradation specifications: Failure to water content and impurity.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0698-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-03-05 |
| Published | 2018-04-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Invagen Pharmaceuticals |
| Distribution | US |
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
Failed impurities/degradation specifications: Failure to water content and impurity
Identifiers
| code_info | Lot #: GE70493, GE70502, GE70512, Exp 8/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0698-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.