Drug product
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.
D-1510-2019
Product summary
- Event
- Event 83327
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 13752 bottles; b) 15696 bottles
- Official record key
drug-enforcement:D-1510-2019
Official wording
Reason: CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Code information: 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
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations