Product: 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.
Reason for recall: CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Recall initiated: 20190716
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated