Drug product
Temozolomide Capsules, 250 mg, 5-count bottle, Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-542-07.
D-1513-2019
Product summary
- Event
- Event 83327
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11472 bottles
- Official record key
drug-enforcement:D-1513-2019
Official wording
Reason: CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Code information: Lot #: A062228, A062227, A062226, A062295, A062294, Exp 08/31/2019; A069325, A069323, Exp 05/31/2020; A072015, Exp 10/31/2020; A076611, A076609, A076608, A076607, Exp 04/30/2021
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations