Deva Holding AS - Cerkezkoy Subesi recalls Temozolomide Capsules, 180 mg, packaged in a) 5-count bottle (NDC 67877-541-07), b) 14-count bottle (NDC 67877-541-14),
Recalled July 31, 2019 · FDA recall D-1512-2019 · Deva Holding AS - Cerkezkoy Subesi
Hazard
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. · FDA Class II
Units
a) 5052 bottles; b) 3816 bottles
Sold at
Nationwide in the USA.
Description
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Product
Temozolomide Capsules, 180 mg, packaged in a) 5-count bottle (NDC 67877-541-07), b) 14-count bottle (NDC 67877-541-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
Manufacturer(s)
Deva Holding AS - Cerkezkoy Subesi
Made in
Turkey
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →