Home / Recalls / Deva Holding AS - Cerkezkoy Subesi / D-1509-2019

D-1509-2019 Class II Terminated

Recalled by Deva Holding AS - Cerkezkoy Subesi — Cerkezkoy, N/A

Recall Details

Product Type
Drugs
Report Date
July 31, 2019
Initiation Date
July 16, 2019
Termination Date
January 6, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
a) 11376 bottles; b) 13620 bottles

Product Description

Temozolomide Capsules, 20 mg, packaged in a) 5-count bottle (NDC 67877-538-07), b) 14-count bottle (NDC 67877-538-14), 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 Pattern

Nationwide in the USA.

Code Information

Lot #: a) A061688, A061687, A061685, Exp 07/31/2019; A068994, Exp 04/30/2020; A071853, Exp 09/30/20; b) A061794, A061833, A061822, Exp 07/31/2019; A069115, Exp 04/30/2020; A071855, A071854, Exp 09/30/2020

Other recalls by Deva Holding AS - Cerkezkoy Subesi

  • D-1511-2019 Class II — Temozolomide Capsules, 140 mg, packaged in a) 5-count bottle (NDC 67877-540-07), (July 16, 2019)
  • D-1512-2019 Class II — Temozolomide Capsules, 180 mg, packaged in a) 5-count bottle (NDC 67877-541-07), (July 16, 2019)
  • D-1510-2019 Class II — Temozolomide Capsules, 100 mg, packaged in a) 5-count bottle (NDC 67877-539-07), (July 16, 2019)
  • D-1513-2019 Class II — Temozolomide Capsules, 250 mg, 5-count bottle, Rx only, Manufactured by: Deva Ho (July 16, 2019)
  • D-1508-2019 Class II — Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 67877-537-07), b (July 16, 2019)