FDAJuly 16, 2019drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

deva holding as cerkezkoy subesidevadeva holding

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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