Temozolomide Capsules — Class II drug recall D-1508-2019
Terminated recall by Deva Holding AS - Cerkezkoy Subesi, reported 2019-07-31, distributed nationwide. CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam p
| Recall number | D-1508-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Deva Holding AS - Cerkezkoy Subesi, Cerkezkoy, N/A, Turkey |
| Recall initiated | 2019-07-16 |
| Classified | 2019-07-23 |
| Reported by FDA | 2019-07-31 |
| Terminated | 2022-01-06 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp |
| NDC | 67877-0537, 67877-0537-07, 67877-0537-14, 67877-0538, 67877-0538-07, 67877-0538-14, 67877-0539, 67877-0539-07, 67877-0539-14, 67877-0540, 67877-0540-07, 67877-0540-14, 67877-0541, 67877-0541-07, 67877-0541-14, 67877-0542, 67877-0542-07 |
| Expiration dates | 2019-08-31, 2020-04-30, 2020-09-30 |
Product
Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 67877-537-07), b) 14-count bottle (NDC 67877-537-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
Reason for recall
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
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-1508-2019. 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.