Drug product
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.
D-1509-2019
Product summary
- Event
- Event 83327
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 11376 bottles; b) 13620 bottles
- Official record key
drug-enforcement:D-1509-2019
Official wording
Reason: CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Code information: Lot #: a) A061688, A061687, A061685, Exp 07/31/2019; A068994, Exp 04/30/2020; A071853, Exp 09/30/20; b) A061794, A061833, A061822, Exp 07/31/2019; A069115, Exp 04/30/2020; A071855, A071854, Exp 09/30/2020
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations