FDA-Drug2019-07-31Class II

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.

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
11472 bottles
Manufactured in
Organize Fatih Bulvar Fatih Bulvar 32 Cerkezkoy, N/A, Cerkezkoy, N/A, Turkey
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, NDC 67877-542-07.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1513-2019

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