FDA recall D-1508-2019

Deva Holding AS - Cerkezkoy Subesi · Class II · drug

Product

Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 67877-537-07), b) 14-count bottle (NDC 67877-537-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.

Reason for recall

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

Distribution

Nationwide in the USA.

Key facts

Status: Terminated
Initiation date: 2019-07-16
Report date: 2019-07-31
Termination date: 2022-01-06
Voluntary/Mandated: Voluntary: Firm initiated
Location: Cerkezkoy, N/A, Turkey

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1508-2019