FDA Recall Temozolomide
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The most recent Recall Enforcement Report that covers this product was initiated on July 16th, 2019 and classified as a Class II recall due to cgmp deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. This recall is currently terminated, and the associated recall number is recall number is D-1512-2019. It pertains to Temozolomide identified by 67877-539 as of 01-06-2022 .
| Recall Number | Recall Initiation Date | Report Date | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|
| D-1512-2019 | 07-16-2019 | 07-31-2019 | 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 | 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 | 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-1509-2019 | 07-16-2019 | 07-31-2019 | 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-1513-2019 | 07-16-2019 | 07-31-2019 | 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 |
| D-1508-2019 | 07-16-2019 | 07-31-2019 | 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 |
What is a Recall Enforcement Report?
A Recall Enforcement Report is an official publication by the FDA that documents all classified drug recalls.
When a company initiates a product removal or correction, the FDA evaluates whether the action meets the criteria for a recall. If it does, the FDA assesses the level of public health risk and assigns a recall classification (Class I, II, or III). Once classified, the recall is published in the Enforcement Report, which includes details such as the product name, affected lot numbers, reason for recall, and scope of distribution.
The Enforcement Report ensures transparency and allows the public and healthcare professionals to stay informed about products that may present a health or safety concern.
Understanding Recall Reports
The recall information provided on this website is sourced directly from official U.S. Food and Drug Administration (FDA) data. It is important to understand that most product recalls are limited in scope and typically involve only specific lots or batches of a product that have been identified as potentially defective or non-compliant with regulatory standards.
Recalls may be initiated voluntarily by the manufacturer or distributor, or they may be mandated by the FDA when a product is found to pose a health risk. A recall does not necessarily mean that all units of a product are unsafe.
If you have concerns about the safety of a medication or healthcare product you are using, it is strongly recommended that you verify the product’s lot number and consult your pharmacist or healthcare provider to determine whether your specific product is affected by the recall.
