Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Deva Holding Anonim Sirketi - Cerkezkoy 2 Uretim Tesisi Subesi | Tekirdag, Turkey | Makes it | No problems foundDec 12, 2023 · 4 inspections, 2 with FDA action |
Recalls
- Jul 16, 2019 · Class II · Deva Holding AS - Cerkezkoy Subesi
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Lots: Lot #: a) A062238, A062118, A062115, A062112, A062100, Exp 08/31/2019; A068946, Exp 04/30/2020; A071733, Exp 09/30/2020; b) A062194, A062181, A62275, A062218, Exp 08/31/2019; A069154, Exp 04/30/2020; A071734, A071783, A071735, Exp 09/30/2020 - Jul 16, 2019 · Class II · Deva Holding AS - Cerkezkoy Subesi
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Lots: 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 - Jul 16, 2019 · Class II · Deva Holding AS - Cerkezkoy Subesi
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Lots: Lot #: a) A061783, A061782, A061781, Exp 07/31/2019; A069128, Exp 05/31/2020; A071923, Exp 09/30/20; b) A061874, A061861, A061896, Exp 07/31/2019; A069326, Exp 05/31/2020; A071924, A071977, A071925, Exp 09/30/2020 - Jul 16, 2019 · Class II · Deva Holding AS - Cerkezkoy Subesi
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Lots: 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 - Jul 16, 2019 · Class II · Deva Holding AS - Cerkezkoy Subesi
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Lots: Lot #: a) A061858, A061857, A061856, A061860, A061859, Exp 07/31/2019; A069401, A069402, Exp 05/31/2020; A071978, Exp 09/30/2020; A076736, A076735, Exp 04/30/2021; b) A062031. A062015, A062014, A062050, A062038, Exp 07/31/2019; A069521, A069470, Exp 05/31/2020; A071979, A072014, A072013, Exp 09/30/… - Jul 16, 2019 · Class II · Deva Holding AS - Cerkezkoy Subesi
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Lots: Lot #: A062228, A062227, A062226, A062295, A062294, Exp 08/31/2019; A069325, A069323, Exp 05/31/2020; A072015, Exp 10/31/2020; A076611, A076609, A076608, A076607, Exp 04/30/2021
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Temozolomide: every company that makes it
- Form
- capsule, oral
- Strength
- 140 mg
- Approval
- ANDA ANDA207658
- On the market since
- Apr 28, 2017
- Package NDCs
67877-540-0767877-540-14- Official label
- DailyMed (National Library of Medicine), updated Jan 9, 2025
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