FDA Drug Class II — Moderate

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.

Hazard

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

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
Brand
Deva Holding AS - Cerkezkoy Subesi
UPC
Lot #: a) A062238, A062118, A062115, A062112, A062100, Exp 08/31/2019; A068946, Exp 04/30/2020; A071733, Exp 09/30/2020; b) A062194, A062181, A62275, A062218, Exp 08/31/2019; A069154, Exp 04/30/2020; A071734, A071783, A071735, Exp 09/30/2020

Units Affected

a) 5736 bottles; b) 8460 bottles