Drug product
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.
D-1508-2019
Product summary
- Event
- Event 83327
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 5736 bottles; b) 8460 bottles
- Official record key
drug-enforcement:D-1508-2019
Official wording
Reason: CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Code information: Lot #: a) A062238, A062118, A062115, A062112, A062100, Exp 08/31/2019; A068946, Exp 04/30/2020; A071733, Exp 09/30/2020; b) A062194, A062181, A62275, A062218, Exp 08/31/2019; A069154, Exp 04/30/2020; A071734, A071783, A071735, Exp 09/30/2020
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations