Drug recall D-1512-2019
Product
Temozolomide Capsules, 180 mg, packaged in a) 5-count bottle (NDC 67877-541-07), b) 14-count bottle (NDC 67877-541-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
Reason for recall
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Lots and codes
Lot #: a) A061858, A061857, A061856, A061860, A061859, Exp 07/31/2019; A069401, A069402, Exp 05/31/2020; A071978, Exp 09/30/2020; A076736, A076735, Exp 04/30/2021; b) A062031. A062015, A062014, A062050, A062038, Exp 07/31/2019; A069521, A069470, Exp 05/31/2020; A071979, A072014, A072013, Exp 09/30/2020; A076739, A076738, A076737, Exp 04/30/2021
Recall details
- Recalling firm
- Deva Holding AS - Cerkezkoy Subesi, Cerkezkoy, N/A
- Quantity
- a) 5052 bottles; b) 3816 bottles
- Distribution
- Nationwide in the USA.
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 16, 2019
- Terminated
- January 6, 2022
Related products
- Temozolomide – drug information
- NDC 67877-539 Temozolomide · Temozolomide 100 mg/1 · Ascend Laboratories, LLC
- NDC 67877-542 Temozolomide · Temozolomide 250 mg/1 · Ascend Laboratories, LLC
- NDC 67877-538 Temozolomide · Temozolomide 20 mg/1 · Ascend Laboratories, LLC
- NDC 67877-540 Temozolomide · Temozolomide 140 mg/1 · Ascend Laboratories, LLC
- NDC 67877-537 Temozolomide · Temozolomide 5 mg/1 · Ascend Laboratories, LLC
- NDC 67877-541 Temozolomide · Temozolomide 180 mg/1 · Ascend Laboratories, LLC