Temozolomide Capsule
FDA Recall NDC 67877-539
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 6 recorded enforcement report(s) associated with Temozolomide (NDC 67877-539). A significant event, classified as Class II, was initiated on Jul 16, 2019 by Ascend Laboratories, Llc. The reported reason for this action was: "CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Jul 16, 2019
Jul 31, 2019
a) 11376 bottles; b) 13620 bottles
Recall Profile & Regulatory Data
Event ID
83327
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Deva Holding AS - Cerkezkoy Subesi
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Jan 06, 2022
Product Description
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.
Batch or Lot Expiration Information
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
Affected Packages Involved in this Recall
67877-537-07Product
67877-537-14Product
67877-538-07Product
67877-538-14Product
67877-539-07Product
67877-539-14Product
67877-540-07Product
67877-540-14Product
67877-541-07Product
67877-541-14Product
67877-542-07Product
Class II Terminated
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Jul 16, 2019
Jul 31, 2019
a) 5052 bottles; b) 3816 bottles
Recall Profile & Regulatory Data
Event ID
83327
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Deva Holding AS - Cerkezkoy Subesi
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Jan 06, 2022
Product Description
Temozolomide Capsules, 180 mg, packaged in a) 5-count bottle (NDC 67877-541-07), b) 14-count bottle (NDC 67877-541-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
Batch or Lot Expiration Information
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 09/30/2020; A076739, A076738, A076737, Exp 04/30/2021
Affected Packages Involved in this Recall
67877-537-07Product
67877-537-14Product
67877-538-07Product
67877-538-14Product
67877-539-07Product
67877-539-14Product
67877-540-07Product
67877-540-14Product
67877-541-07Product
67877-541-14Product
67877-542-07Product
Class II Terminated
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Jul 16, 2019
Jul 31, 2019
a) 13752 bottles; b) 15696 bottles
Recall Profile & Regulatory Data
Event ID
83327
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Deva Holding AS - Cerkezkoy Subesi
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Jan 06, 2022
Product Description
Temozolomide Capsules, 100 mg, packaged in a) 5-count bottle (NDC 67877-539-07), b) 14-count bottle (NDC 67877-539-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
Batch or Lot Expiration Information
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
Affected Packages Involved in this Recall
67877-537-07Product
67877-537-14Product
67877-538-07Product
67877-538-14Product
67877-539-07Product
67877-539-14Product
67877-540-07Product
67877-540-14Product
67877-541-07Product
67877-541-14Product
67877-542-07Product
Class II Terminated
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Jul 16, 2019
Jul 31, 2019
a) 7380 bottles; b) 10332 bottles
Recall Profile & Regulatory Data
Event ID
83327
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Deva Holding AS - Cerkezkoy Subesi
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Jan 06, 2022
Product Description
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.
Batch or Lot Expiration Information
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
Affected Packages Involved in this Recall
67877-537-07Product
67877-537-14Product
67877-538-07Product
67877-538-14Product
67877-539-07Product
67877-539-14Product
67877-540-07Product
67877-540-14Product
67877-541-07Product
67877-541-14Product
67877-542-07Product
Class II Terminated
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Jul 16, 2019
Jul 31, 2019
11472 bottles
Recall Profile & Regulatory Data
Event ID
83327
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Deva Holding AS - Cerkezkoy Subesi
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Jan 06, 2022
Product Description
Temozolomide Capsules, 250 mg, 5-count bottle, Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-542-07.
Batch or Lot Expiration Information
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
Affected Packages Involved in this Recall
67877-537-07Product
67877-537-14Product
67877-538-07Product
67877-538-14Product
67877-539-07Product
67877-539-14Product
67877-540-07Product
67877-540-14Product
67877-541-07Product
67877-541-14Product
67877-542-07Product
Class II Terminated
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Jul 16, 2019
Jul 31, 2019
a) 5736 bottles; b) 8460 bottles
Recall Profile & Regulatory Data
Event ID
83327
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Deva Holding AS - Cerkezkoy Subesi
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Jan 06, 2022
Product Description
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.
Batch or Lot Expiration Information
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
Affected Packages Involved in this Recall
67877-537-07Product
67877-537-14Product
67877-538-07Product
67877-538-14Product
67877-539-07Product
67877-539-14Product
67877-540-07Product
67877-540-14Product
67877-541-07Product
67877-541-14Product
67877-542-07Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
