CLASS II Drug recall · Reported 31 Jul 2019 · FDA Enforcement Report
Temozolomide Capsules, 20 mg recalled by Deva Holding AS - Cerkezkoy
Deva Holding AS - Cerkezkoy Subesi is recalling Temozolomide Capsules, 20 mg, distributed nationwide in the US. The recall was initiated on 16 Jul 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1509-2019
- FDA event ID
- 83327
- Recalling firm
- Deva Holding AS - Cerkezkoy Subesi, Cerkezkoy, N/A
- Brand
- Temozolomide
- Manufacturer
- Ascend Laboratories, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jul 2019
- FDA classified
- 23 Jul 2019
- Reported
- 31 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 16 Jul 2019 | Recall initiated by company | |
| 23 Jul 2019 | Classified by FDA | +7 days |
| 31 Jul 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Product as listed by the FDA
Temozolomide Capsules, 20 mg, packaged in a) 5-count bottle (NDC 67877-538-07), b) 14-count bottle (NDC 67877-538-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Which lots are affected?
Lot #: a) A061688, A061687, A061685, Exp 07/31/2019; A068994, Exp 04/30/2020; A071853, Exp 09/30/20; b) A061794, A061833, A061822, Exp 07/31/2019; A069115, Exp 04/30/2020; A071855, A071854, Exp 09/30/2020
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 83327This product is part of a recall event; the main page for the event is Temozolomide Capsules, 180 mg recalled by Deva Holding AS - Cerkezkoy.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Temozolomide Capsules, 180 mg recalled by Deva Holding AS - CerkezkoyTemozolomide | Deva Holding AS - Cerkezkoy Subesi | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Temozolomide Capsules, 100 mg recalled by Deva Holding AS - CerkezkoyTemozolomide | Deva Holding AS - Cerkezkoy Subesi | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Temozolomide Capsules, 250 mg recalled by Deva Holding AS - CerkezkoyTemozolomide | Deva Holding AS - Cerkezkoy Subesi | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Temozolomide Capsules, 140 mg recalled by Deva Holding AS - CerkezkoyTemozolomide | Deva Holding AS - Cerkezkoy Subesi | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Temozolomide Capsules, 5 mg recalled by Deva Holding AS - CerkezkoyTemozolomide | Deva Holding AS - Cerkezkoy Subesi | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Deva Holding AS - Cerkezkoy Subesi
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Temozolomide Capsules, 5 mg recalled by Deva Holding AS - CerkezkoyTemozolomide | Deva Holding AS - Cerkezkoy Subesi | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Temozolomide Capsules, 140 mg recalled by Deva Holding AS - CerkezkoyTemozolomide | Deva Holding AS - Cerkezkoy Subesi | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Temozolomide Capsules, 250 mg recalled by Deva Holding AS - CerkezkoyTemozolomide | Deva Holding AS - Cerkezkoy Subesi | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Temozolomide Capsules, 100 mg recalled by Deva Holding AS - CerkezkoyTemozolomide | Deva Holding AS - Cerkezkoy Subesi | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Temozolomide Capsules, 180 mg recalled by Deva Holding AS - CerkezkoyTemozolomide | Deva Holding AS - Cerkezkoy Subesi | Manufacturing (CGMP) Deviations | Nationwide |
Other Temozolomide recalls
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Product label: Temozolomide Capsules, 5mg recalledTemozolomide | Rising Pharma Holding | Potency & Assay | Nationwide |
| Drug | CLASS II | Temozolomide Capsules, 5 mg recalled by Deva Holding AS - CerkezkoyTemozolomide | Deva Holding AS - Cerkezkoy Subesi | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Temozolomide Capsules, 140 mg recalled by Deva Holding AS - CerkezkoyTemozolomide | Deva Holding AS - Cerkezkoy Subesi | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Temozolomide Capsules, 250 mg recalled by Deva Holding AS - CerkezkoyTemozolomide | Deva Holding AS - Cerkezkoy Subesi | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Temozolomide Capsules, 100 mg recalled by Deva Holding AS - CerkezkoyTemozolomide | Deva Holding AS - Cerkezkoy Subesi | Manufacturing (CGMP) Deviations | Nationwide |