FDA Drug recall D-1511-2019
Temozolomide Capsules, 140 mg, packaged in a) 5-count bottle (NDC 67877-540-07), b) 14-count bottle (NDC 67877-540-14), Rx only, Manufactur…
- FDA Drug
- Class II
- terminated
- Published 2019-07-31
On 2019-07-31 the FDA classified a Class II recall of Temozolomide Capsules, 140 mg, packaged in a) 5-count bottle (NDC 67877-540-07), b) 14-count bottle (NDC 67877-540-14), Rx only, Manufactur… by Deva Holding As Cerkezkoy Subesi, citing CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1511-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-16 |
| Published | 2019-07-31 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Deva Holding As Cerkezkoy Subesi |
| Distribution | US |
Product
Temozolomide Capsules, 140 mg, packaged in a) 5-count bottle (NDC 67877-540-07), b) 14-count bottle (NDC 67877-540-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
Reason
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Identifiers
| ndc | 67877-537-07 |
|---|---|
| ndc | 67877-537-14 |
| ndc | 67877-538-07 |
| ndc | 67877-538-14 |
| ndc | 67877-539-07 |
| ndc | 67877-539-14 |
| ndc | 67877-540-07 |
| ndc | 67877-540-14 |
| ndc | 67877-541-07 |
| ndc | 67877-541-14 |
| ndc | 67877-542-07 |
| code_info | Lot #: a) A063581, A063462, A063460, Exp 09/30/2019; A063582, Exp 10/31/2019; A069129, Exp 05/31/2020; A071801, Exp 0…Lot #: a) A063581, A063462, A063460, Exp 09/30/2019; A063582, Exp 10/31/2019; A069129, Exp 05/31/2020; A071801, Exp 09/30/2020; b) A063639, A063624, A063609, Exp 09/30/2019; A063657, Exp 10/31/2019; A069366, Exp 05/31/2020; A071817, A071819, A071818, Exp 09/30/2020 |
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-1511-2019%22
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