Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported July 31, 2019
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.
Deva Holding As - Cerkezkoy Subesi recalled Temozolomide Capsules, 100 mg, packaged in a) 5-count bottle (NDC 67877-539-07), b) 14-co… - a moderate-severity action.
Temozolomide Capsules, 100 mg, packaged in a) 5-count bottle (NDC 67877-539-07), b) 14-co… was recalled by Deva Holding As - Cerkezkoy Subesi in July 31, 2019. Reason: CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam …. Check the official notice for the remedy. Verify recall #D-1510-2019 with the FDA Drug before acting.
The recall
Deva Holding As - Cerkezkoy Subesi issued this moderate-severity FDA Drug recall-CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam ….
- Moderate
- severity level
- Class II
- classification
- July 31, 2019
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1510-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1510-2019) was formally reported on July 31, 2019, with the manufacturer initiating the action on July 16, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Deva Holding As - Cerkezkoy Subesi is listed as the recalling firm, operating out of Cerkezkoy, N/A. Federal records list the affected scope as a) 13752 bottles; b) 15696 bottles.
The documented reason for this recall is: CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. Distribution data in the federal record shows the product reached: Nationwide in the USA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,731 children & baby products recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
a) 13752 bottles; b) 15696 bottles
Related Recalls
6
0 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-1510-2019 |
| Date reported | July 31, 2019 |
| Date initiated | July 16, 2019 |
| Recalling firm | Deva Holding As - Cerkezkoy Subesi |
| Firm location | Cerkezkoy, N/A |
| Affected scope | a) 13752 bottles; b) 15696 bottles |
| Distribution | Nationwide in the USA. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-1510-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Deva Holding As - Cerkezkoy Subesi. Units affected: a) 13752 bottles; b) 15696 bottles.
Why was this product recalled? ▼
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 31, 2019. Severity: Moderate. Recall number: D-1510-2019.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the USA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1510-2019) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported July 31, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.