Multi-event July 2019 FDA Recall Temozolomide by Deva Holding As - Cerkezkoy Subesi
This Multi-event Class II drug recall was voluntarily initiated by Deva Holding As - Cerkezkoy Subesi on July 16, 2019 for the product Temozolomide. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1509-2019
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
07-16-2019
07-31-2019
a) 11376 bottles; b) 13620 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Deva Holding AS - Cerkezkoy Subesi
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA.
01-06-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Recall Number: D-1512-2019
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
07-16-2019
07-31-2019
a) 5052 bottles; b) 3816 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Deva Holding AS - Cerkezkoy Subesi
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA.
01-06-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Recall Number: D-1510-2019
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
07-16-2019
07-31-2019
a) 13752 bottles; b) 15696 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Deva Holding AS - Cerkezkoy Subesi
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA.
01-06-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Recall Number: D-1511-2019
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
07-16-2019
07-31-2019
a) 7380 bottles; b) 10332 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Deva Holding AS - Cerkezkoy Subesi
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA.
01-06-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
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
Recall Number: D-1513-2019
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
07-16-2019
07-31-2019
11472 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Deva Holding AS - Cerkezkoy Subesi
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA.
01-06-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Recall Number: D-1508-2019
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
07-16-2019
07-31-2019
a) 5736 bottles; b) 8460 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Deva Holding AS - Cerkezkoy Subesi
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA.
01-06-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
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
