Drug recall D-1510-2019
Product
Temozolomide Capsules, 100 mg, packaged in a) 5-count bottle (NDC 67877-539-07), b) 14-count bottle (NDC 67877-539-14), 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) A061783, A061782, A061781, Exp 07/31/2019; A069128, Exp 05/31/2020; A071923, Exp 09/30/20; b) A061874, A061861, A061896, Exp 07/31/2019; A069326, Exp 05/31/2020; A071924, A071977, A071925, Exp 09/30/2020
Recall details
- Recalling firm
- Deva Holding AS - Cerkezkoy Subesi, Cerkezkoy, N/A
- Quantity
- a) 13752 bottles; b) 15696 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