FDA-Drug2019-07-31Class II
Temozolomide Capsules, 100 mg, packaged in a) 5-count bottle (NDC 67877-539-07), b) 14-count bottle (NDC 67877-539-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
Deva Holding AS - Cerkezkoy Subesi
Hazard
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Sold states
Nationwide in the USA.
Affected count
a) 13752 bottles; b) 15696 bottles
Manufactured in
Organize Fatih Bulvar Fatih Bulvar 32 Cerkezkoy, N/A, Cerkezkoy, N/A, Turkey
Products
Temozolomide Capsules, 100 mg, packaged in a) 5-count bottle (NDC 67877-539-07), b) 14-count bottle (NDC 67877-539-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1510-2019Don't want to check this manually?
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