Medications & Supplements/Prescription Drugs

Deva Holding AS - Cerkezkoy Subesi: Temozolomide Capsules Recalled Due to Potential Beta-Lactam Contamination

Agency Publication Date: July 23, 2019

Summary

Deva Holding AS is recalling approximately 54,768 bottles of Temozolomide capsules (generic for Temodar) across six different strengths (5 mg, 20 mg, 100 mg, 140 mg, 180 mg, and 250 mg). The recall was initiated because the manufacturing facility failed to prevent potential cross-contamination with beta-lactam products (such as penicillin or cephalosporin antibiotics). If these chemotherapy capsules contain traces of antibiotics, patients with severe allergies could experience a dangerous reaction.

Risk

The product may be contaminated with beta-lactam antibiotics. Patients who are highly sensitive or allergic to penicillin or other beta-lactams could suffer severe, potentially life-threatening allergic reactions if they consume this medication.

What You Should Do

Check your medication bottles for the brand name Temozolomide and the distributor name Ascend Laboratories, LLC.
Verify if your lot number and expiration date match the affected list: for 5 mg (NDC 67877-537-07/14), check for lots A062238, A062118, A062115, A062112, A062100, A068946, A071733, A062194, A062181, A62275, A062218, A069154, A071734, A071783, or A071735.
For 20 mg (NDC 67877-538-07/14), check for lots A061688, A061687, A061685, A068994, A071853, A061794, A061833, A061822, A069115, A071855, or A071854.
For 100 mg (NDC 67877-539-07/14), check for lots A061783, A061782, A061781, A069128, A071923, A061874, A061861, A061896, A069326, A071924, A071977, or A071925.
For other strengths (140 mg, 180 mg, 250 mg), refer to the specific lot list including A063581, A063462, A063460, A069129, A071801, A061858, A069401, A071978, A076736, A062228, A069325, A072015, or A076611 among others.
Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription before you stop taking this medication.
Return any unused capsules to your pharmacy for a refund and contact Deva Holding AS or Ascend Laboratories for further instructions regarding the return process.
For additional questions, contact the FDA Consumer Complaint line at 1-888-463-6332 or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Full refund for unused prescription medication.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Temozolomide Capsules, 5 mg (5-count and 14-count bottles)

Model:

NDC 67877-537-07

NDC 67877-537-14

Lot Numbers:

A062238 (Exp 08/31/2019)

A062118 (Exp 08/31/2019)

A062115 (Exp 08/31/2019)

A062112 (Exp 08/31/2019)

A062100 (Exp 08/31/2019)

A068946 (Exp 04/30/2020)

A071733 (Exp 09/30/2020)

A062194 (Exp 08/31/2019)

A062181 (Exp 08/31/2019)

A62275 (Exp 08/31/2019)

A062218 (Exp 08/31/2019)

A069154 (Exp 04/30/2020)

A071734 (Exp 09/30/2020)

A071783 (Exp 09/30/2020)

A071735 (Exp 09/30/2020)

Date Ranges: 08/31/2019, 04/30/2020, 09/30/2020

Product: Temozolomide Capsules, 20 mg (5-count and 14-count bottles)

Model:

NDC 67877-538-07

NDC 67877-538-14

Lot Numbers:

A061688 (Exp 07/31/2019)

A061687 (Exp 07/31/2019)

A061685 (Exp 07/31/2019)

A068994 (Exp 04/30/2020)

A071853 (Exp 09/30/20)

A061794 (Exp 07/31/2019)

A061833 (Exp 07/31/2019)

A061822 (Exp 07/31/2019)

A069115 (Exp 04/30/2020)

A071855 (Exp 09/30/2020)

A071854 (Exp 09/30/2020)

Date Ranges: 07/31/2019, 04/30/2020, 09/30/2020

Product: Temozolomide Capsules, 100 mg (5-count and 14-count bottles)

Model:

NDC 67877-539-07

NDC 67877-539-14

Lot Numbers:

A061783 (Exp 07/31/2019)

A061782 (Exp 07/31/2019)

A061781 (Exp 07/31/2019)

A069128 (Exp 05/31/2020)

A071923 (Exp 09/30/20)

A061874 (Exp 07/31/2019)

A061861 (Exp 07/31/2019)

A061896 (Exp 07/31/2019)

A069326 (Exp 05/31/2020)

A071924 (Exp 09/30/2020)

A071977 (Exp 09/30/2020)

A071925 (Exp 09/30/2020)

Date Ranges: 07/31/2019, 05/31/2020, 09/30/2020

Product: Temozolomide Capsules, 140 mg (5-count and 14-count bottles)

Model:

NDC 67877-540-07

NDC 67877-540-14

Lot Numbers:

A063581 (Exp 09/30/2019)

A063462 (Exp 09/30/2019)

A063460 (Exp 09/30/2019)

A063582 (Exp 10/31/2019)

A069129 (Exp 05/31/2020)

A071801 (Exp 09/30/2020)

A063639 (Exp 09/30/2019)

A063624 (Exp 09/30/2019)

A063609 (Exp 09/30/2019)

A063657 (Exp 10/31/2019)

A069366 (Exp 05/31/2020)

A071817 (Exp 09/30/2020)

A071819 (Exp 09/30/2020)

A071818 (Exp 09/30/2020)

Date Ranges: 09/30/2019, 10/31/2019, 05/31/2020, 09/30/2020

Product: Temozolomide Capsules, 180 mg (5-count and 14-count bottles)

Model:

NDC 67877-541-07

NDC 67877-541-14

Lot Numbers:

A061858 (Exp 07/31/2019)

A061857 (Exp 07/31/2019)

A061856 (Exp 07/31/2019)

A061860 (Exp 07/31/2019)

A061859 (Exp 07/31/2019)

A069401 (Exp 05/31/2020)

A069402 (Exp 05/31/2020)

A071978 (Exp 09/30/2020)

A076736 (Exp 04/30/2021)

A076735 (Exp 04/30/2021)

A062031 (Exp 07/31/2019)

A062015 (Exp 07/31/2019)

A062014 (Exp 07/31/2019)

A062050 (Exp 07/31/2019)

A062038 (Exp 07/31/2019)

A069521 (Exp 05/31/2020)

A069470 (Exp 05/31/2020)

A071979 (Exp 09/30/2020)

A072014 (Exp 09/30/2020)

A072013 (Exp 09/30/2020)

A076739 (Exp 04/30/2021)

A076738 (Exp 04/30/2021)

A076737 (Exp 04/30/2021)

Date Ranges: 07/31/2019, 05/31/2020, 09/30/2020, 04/30/2021

Product: Temozolomide Capsules, 250 mg (5-count bottle)

Model:

NDC 67877-542-07

Lot Numbers:

A062228 (Exp 08/31/2019)

A062227 (Exp 08/31/2019)

A062226 (Exp 08/31/2019)

A062295 (Exp 08/31/2019)

A062294 (Exp 08/31/2019)

A069325 (Exp 05/31/2020)

A069323 (Exp 05/31/2020)

A072015 (Exp 10/31/2020)

A076611 (Exp 04/30/2021)

A076609 (Exp 04/30/2021)

A076608 (Exp 04/30/2021)

A076607 (Exp 04/30/2021)

Date Ranges: 08/31/2019, 05/31/2020, 10/31/2020, 04/30/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83327

Status: Resolved

Manufacturer: Deva Holding AS - Cerkezkoy Subesi

Sold By: Ascend Laboratories, LLC

Manufactured In: Turkey

Units Affected: 6 products (a) 5736 bottles; b) 8460 bottles; a) 11376 bottles; b) 13620 bottles; a) 13752 bottles; b) 15696 bottles; a) 7380 bottles; b) 10332 bottles; a) 5052 bottles; b) 3816 bottles; 11472 bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication bottles for the brand name Temozolomide and the distributor name Ascend Laboratories, LLC.

Verify if your lot number and expiration date match the affected list: for 5 mg (NDC 67877-537-07/14), check for lots A062238, A062118, A062115, A062112, A062100, A068946, A071733, A062194, A062181, A62275, A062218, A069154, A071734, A071783, or A071735.

For 20 mg (NDC 67877-538-07/14), check for lots A061688, A061687, A061685, A068994, A071853, A061794, A061833, A061822, A069115, A071855, or A071854.

For 100 mg (NDC 67877-539-07/14), check for lots A061783, A061782, A061781, A069128, A071923, A061874, A061861, A061896, A069326, A071924, A071977, or A071925.

For other strengths (140 mg, 180 mg, 250 mg), refer to the specific lot list including A063581, A063462, A063460, A069129, A071801, A061858, A069401, A071978, A076736, A062228, A069325, A072015, or A076611 among others.

Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription before you stop taking this medication.

Return any unused capsules to your pharmacy for a refund and contact Deva Holding AS or Ascend Laboratories for further instructions regarding the return process.

For additional questions, contact the FDA Consumer Complaint line at 1-888-463-6332 or visit www.fda.gov/safety/recalls.

Affected Products

Product: Temozolomide Capsules, 5 mg (5-count and 14-count bottles)

Model:

NDC 67877-537-07

NDC 67877-537-14

Lot Numbers:

A062238 (Exp 08/31/2019)

A062118 (Exp 08/31/2019)

A062115 (Exp 08/31/2019)

A062112 (Exp 08/31/2019)

A062100 (Exp 08/31/2019)

A068946 (Exp 04/30/2020)

A071733 (Exp 09/30/2020)

A062194 (Exp 08/31/2019)

A062181 (Exp 08/31/2019)

A62275 (Exp 08/31/2019)

A062218 (Exp 08/31/2019)

A069154 (Exp 04/30/2020)

A071734 (Exp 09/30/2020)

A071783 (Exp 09/30/2020)

A071735 (Exp 09/30/2020)

Date Ranges: 08/31/2019, 04/30/2020, 09/30/2020

Product: Temozolomide Capsules, 20 mg (5-count and 14-count bottles)

Model:

NDC 67877-538-07

NDC 67877-538-14

Lot Numbers:

A061688 (Exp 07/31/2019)

A061687 (Exp 07/31/2019)

A061685 (Exp 07/31/2019)

A068994 (Exp 04/30/2020)

A071853 (Exp 09/30/20)

A061794 (Exp 07/31/2019)

A061833 (Exp 07/31/2019)

A061822 (Exp 07/31/2019)

A069115 (Exp 04/30/2020)

A071855 (Exp 09/30/2020)

A071854 (Exp 09/30/2020)

Date Ranges: 07/31/2019, 04/30/2020, 09/30/2020

Product: Temozolomide Capsules, 100 mg (5-count and 14-count bottles)

Model:

NDC 67877-539-07

NDC 67877-539-14

Lot Numbers:

A061783 (Exp 07/31/2019)

A061782 (Exp 07/31/2019)

A061781 (Exp 07/31/2019)

A069128 (Exp 05/31/2020)

A071923 (Exp 09/30/20)

A061874 (Exp 07/31/2019)

A061861 (Exp 07/31/2019)

A061896 (Exp 07/31/2019)

A069326 (Exp 05/31/2020)

A071924 (Exp 09/30/2020)

A071977 (Exp 09/30/2020)

A071925 (Exp 09/30/2020)

Date Ranges: 07/31/2019, 05/31/2020, 09/30/2020

Product: Temozolomide Capsules, 140 mg (5-count and 14-count bottles)

Model:

NDC 67877-540-07

NDC 67877-540-14

Lot Numbers:

A063581 (Exp 09/30/2019)

A063462 (Exp 09/30/2019)

A063460 (Exp 09/30/2019)

A063582 (Exp 10/31/2019)

A069129 (Exp 05/31/2020)

A071801 (Exp 09/30/2020)

A063639 (Exp 09/30/2019)

A063624 (Exp 09/30/2019)

A063609 (Exp 09/30/2019)

A063657 (Exp 10/31/2019)

A069366 (Exp 05/31/2020)

A071817 (Exp 09/30/2020)

A071819 (Exp 09/30/2020)

A071818 (Exp 09/30/2020)

Date Ranges: 09/30/2019, 10/31/2019, 05/31/2020, 09/30/2020

Product: Temozolomide Capsules, 180 mg (5-count and 14-count bottles)

Model:

NDC 67877-541-07

NDC 67877-541-14

Lot Numbers:

A061858 (Exp 07/31/2019)

A061857 (Exp 07/31/2019)

A061856 (Exp 07/31/2019)

A061860 (Exp 07/31/2019)

A061859 (Exp 07/31/2019)

A069401 (Exp 05/31/2020)

A069402 (Exp 05/31/2020)

A071978 (Exp 09/30/2020)

A076736 (Exp 04/30/2021)

A076735 (Exp 04/30/2021)

A062031 (Exp 07/31/2019)

A062015 (Exp 07/31/2019)

A062014 (Exp 07/31/2019)

A062050 (Exp 07/31/2019)

A062038 (Exp 07/31/2019)

A069521 (Exp 05/31/2020)

A069470 (Exp 05/31/2020)

A071979 (Exp 09/30/2020)

A072014 (Exp 09/30/2020)

A072013 (Exp 09/30/2020)

A076739 (Exp 04/30/2021)

A076738 (Exp 04/30/2021)

A076737 (Exp 04/30/2021)

Date Ranges: 07/31/2019, 05/31/2020, 09/30/2020, 04/30/2021

Product: Temozolomide Capsules, 250 mg (5-count bottle)

Model:

NDC 67877-542-07

Lot Numbers:

A062228 (Exp 08/31/2019)

A062227 (Exp 08/31/2019)

A062226 (Exp 08/31/2019)

A062295 (Exp 08/31/2019)

A062294 (Exp 08/31/2019)

A069325 (Exp 05/31/2020)

A069323 (Exp 05/31/2020)

A072015 (Exp 10/31/2020)

A076611 (Exp 04/30/2021)

A076609 (Exp 04/30/2021)

A076608 (Exp 04/30/2021)

A076607 (Exp 04/30/2021)

Date Ranges: 08/31/2019, 05/31/2020, 10/31/2020, 04/30/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83327

Status: Resolved

Manufacturer: Deva Holding AS - Cerkezkoy Subesi

Sold By: Ascend Laboratories, LLC

Manufactured In: Turkey

Distributed To: Nationwide