Recall Enforment Report D-1509-2019

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Deva Holding AS - Cerkezkoy Subesi, originally initiated on 07-16-2019 for 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. The product was recalled due to cgmp deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number	Recall Initiation Date	Report Date	Recall Classification	Quantity	Product Description	Recall Reason	Status
D-1509-2019	07-16-2019	07-31-2019	Class II	a) 11376 bottles; b) 13620 bottles	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.	CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.	Terminated
D-1508-2019	07-16-2019	07-31-2019	Class II	a) 5736 bottles; b) 8460 bottles	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.	CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.	Terminated
D-1512-2019	07-16-2019	07-31-2019	Class II	a) 5052 bottles; b) 3816 bottles	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.	CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.	Terminated
D-1510-2019	07-16-2019	07-31-2019	Class II	a) 13752 bottles; b) 15696 bottles	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.	CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.	Terminated
D-1511-2019	07-16-2019	07-31-2019	Class II	a) 7380 bottles; b) 10332 bottles	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.	CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.	Terminated
D-1513-2019	07-16-2019	07-31-2019	Class II	11472 bottles	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.	CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.	Terminated

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
67877-537	Temozolomide	Temozolomide	Capsule	Oral	Ascend Laboratories, Llc	Human Prescription Drug
67877-538	Temozolomide	Temozolomide	Capsule	Oral	Ascend Laboratories, Llc	Human Prescription Drug
67877-539	Temozolomide	Temozolomide	Capsule	Oral	Ascend Laboratories, Llc	Human Prescription Drug
67877-540	Temozolomide	Temozolomide	Capsule	Oral	Ascend Laboratories, Llc	Human Prescription Drug
67877-541	Temozolomide	Temozolomide	Capsule	Oral	Ascend Laboratories, Llc	Human Prescription Drug
67877-542	Temozolomide	Temozolomide	Capsule	Oral	Ascend Laboratories, Llc	Human Prescription Drug

Field Name	Field Value
Event ID	83327 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1509-2019 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	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 What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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.
Reason For Recall	CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	a) 11376 bottles; b) 13620 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	07-31-2019
Recall Initiation Date	07-16-2019 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	01-06-2022 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	E-Mail Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Deva Holding AS - Cerkezkoy Subesi
Code Info	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 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	67877-537-07; 67877-537-14; 67877-538-07; 67877-538-14; 67877-539-07; 67877-539-14; 67877-540-07; 67877-540-14; 67877-541-07; 67877-541-14; 67877-542-07
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	83327 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1508-2019 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	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 What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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.
Reason For Recall	CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	a) 5736 bottles; b) 8460 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	07-31-2019
Recall Initiation Date	07-16-2019 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	01-06-2022 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	E-Mail Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Deva Holding AS - Cerkezkoy Subesi
Code Info	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 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	67877-537-07; 67877-537-14; 67877-538-07; 67877-538-14; 67877-539-07; 67877-539-14; 67877-540-07; 67877-540-14; 67877-541-07; 67877-541-14; 67877-542-07
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	83327 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1512-2019 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	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 What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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.
Reason For Recall	CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	a) 5052 bottles; b) 3816 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	07-31-2019
Recall Initiation Date	07-16-2019 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	01-06-2022 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	E-Mail Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Deva Holding AS - Cerkezkoy Subesi
Code Info	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 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	67877-537-07; 67877-537-14; 67877-538-07; 67877-538-14; 67877-539-07; 67877-539-14; 67877-540-07; 67877-540-14; 67877-541-07; 67877-541-14; 67877-542-07
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	83327 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1510-2019 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	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 What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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.
Reason For Recall	CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	a) 13752 bottles; b) 15696 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	07-31-2019
Recall Initiation Date	07-16-2019 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	01-06-2022 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	E-Mail Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Deva Holding AS - Cerkezkoy Subesi
Code Info	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 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	67877-537-07; 67877-537-14; 67877-538-07; 67877-538-14; 67877-539-07; 67877-539-14; 67877-540-07; 67877-540-14; 67877-541-07; 67877-541-14; 67877-542-07
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	83327 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1511-2019 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	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 What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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.
Reason For Recall	CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	a) 7380 bottles; b) 10332 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	07-31-2019
Recall Initiation Date	07-16-2019 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	01-06-2022 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	E-Mail Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Deva Holding AS - Cerkezkoy Subesi
Code Info	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 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	67877-537-07; 67877-537-14; 67877-538-07; 67877-538-14; 67877-539-07; 67877-539-14; 67877-540-07; 67877-540-14; 67877-541-07; 67877-541-14; 67877-542-07
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	83327 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1513-2019 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	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 What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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.
Reason For Recall	CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	11472 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	07-31-2019
Recall Initiation Date	07-16-2019 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	01-06-2022 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	E-Mail Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Deva Holding AS - Cerkezkoy Subesi
Code Info	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 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	67877-537-07; 67877-537-14; 67877-538-07; 67877-538-14; 67877-539-07; 67877-539-14; 67877-540-07; 67877-540-14; 67877-541-07; 67877-541-14; 67877-542-07
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.