Decitabine for Injection — Class III drug recall D-0698-2018
Terminated recall by InvaGen Pharmaceuticals, Inc., reported 2018-04-18, distributed nationwide. Failed impurities/degradation specifications: Failure to water content and impurity
| Recall number | D-0698-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | InvaGen Pharmaceuticals, Inc., Central Islip, NY, United States |
| Recall initiated | 2018-03-05 |
| Classified | 2018-04-26 |
| Reported by FDA | 2018-04-18 |
| Terminated | 2021-01-20 |
| Distributed | Nationwide (US) |
| Quantity | 3,222 vials |
| Reason classes | specification failure |
| NDC | 69097-0285-37 |
| Lot numbers | GE70493, GE70502, GE70512 |
| Expiration dates | 2019-08 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0698-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.