Recall: D-1510-2019

Class II - Potentially Harmful

Class IIClassification

2019-07-16Initiated

TerminatedStatus

Deva Holding AS - Cerkezkoy SuFirm

Product

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.

Reason

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

Distribution

Nationwide in the USA.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.