Drug recall D-1513-2019
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.
Reason for recall
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Lots and codes
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
Recall details
- Recalling firm
- Deva Holding AS - Cerkezkoy Subesi, Cerkezkoy, N/A
- Quantity
- 11472 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