Drug product
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.
D-1511-2019
Product summary
- Event
- Event 83327
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 7380 bottles; b) 10332 bottles
- Official record key
drug-enforcement:D-1511-2019
Official wording
Reason: CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Code information: Lot #: a) A063581, A063462, A063460, Exp 09/30/2019; A063582, Exp 10/31/2019; A069129, Exp 05/31/2020; A071801, Exp 09/30/2020; b) A063639, A063624, A063609, Exp 09/30/2019; A063657, Exp 10/31/2019; A069366, Exp 05/31/2020; A071817, A071819, A071818, Exp 09/30/2020
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations