Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 67877-537-07), b) 14-count bottle (NDC 67877-537-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.

Recall Number: D-1508-2019

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, 5 mg, packaged in a) 5-count bottle (NDC 67877-537-07), b) 14-count bottle (NDC 67877-537-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.