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.

Recall Number: D-1513-2019

Firm: Deva Holding AS - Cerkezkoy Subesi

Classification: Class II

Status: Terminated

Report Date: 20190731

Initiation Date: 20190716

Termination Date: 20220106

CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.

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.