Class II · Moderate risk Ongoing
Product label: Temozolomide Capsules
Reason Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Temozolomide Capsules
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
What was recalled
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.
- Recalling firm
- Deva Holding AS - Cerkezkoy Subesi
- NDC code
- 67877-537-07
- Origin
- N/A, Turkey
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1508-2019
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Temozolomide recalls
See all
Class II · Moderate risk Terminated
Temozolomide Capsules
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class II · Moderate risk Terminated
Temozolomide Capsules
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class II · Moderate risk Terminated
Temozolomide Capsules
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class II · Moderate risk Terminated
Temozolomide Capsules
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
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