FDA Drug Class II — Moderate

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.

Hazard

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

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,
Brand
Deva Holding AS - Cerkezkoy Subesi
UPC
Lot #: A062228, A062227, A062226, A062295, A062294, Exp 08/31/2019; A069325, A069323, Exp 05/31/2020; A072015, Exp 10/31/2020; A076611, A076609, A076608, A076607, Exp 04/30/2021

Units Affected

11472 bottles