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Chemotherapy Tablets Recalled


August 01, 2019

Cross-contamination concerns have prompted the recall of multiple lots of temozolomide capsules. According to the July 31, 2019, US Food and Drug Administration (FDA) Enforcement Report, the chemotherapy medication may have been cross-contaminated with beta lactam products during manufacturing.

The recall affects various strengths of temozolomide capsules manufactured by Deva Holding A.S. and distributed throughout the United States by Ascend Laboratories:

  • 5-mg temozolomide capsules in 5-count bottles (NDC 67877-537-07) from lots A062238, A062118, A062115, A062112, and A062100 (Exp. 8/31/19); A068946 (Exp. 4/30/20); and A071733 (Exp. 9/30/20);
  • 5-mg temozolomide capsules in 14-count bottles (NDC 67877-537-14) from lots A062194, A062181, A62275, and A062218 (Exp. 8/31/19); A069154 (Exp. 4/30/20); A071734, A071783, and A071735 (Exp. 9/30/20);
  • 20-mg temozolomide capsules in 5-count bottles (NDC 67877-538-07) from lots A061688, A061687, and A061685 (Exp. 7/31/19); A068994 (Exp. 4/30/20); and A071853 (Exp. 9/30/20);
  • 20-mg temozolomide capsules in 14-count bottles (NDC 67877-538-14) from lots A061794, A061833, and A061822 (Exp. 7/31/19); A069115 (Exp. 4/30/20); and A071855 and A071854 (Exp. 9/30/20);
  • 100-mg temozolomide capsules in 5-count bottles (NDC 67877-539-07) from lots A061783, A061782, and A061781 (Exp. 7/31/19); A069128 (Exp. 5/31/20); and A071923 (Exp. 9/30/20);
  • 100-mg temozolomide capsules in 14-count bottles (NDC 67877-539-14) from lots A061874, A061861, and A061896 (Exp. 7/31/19); A069326 (Exp. 5/31/20); A071924, A071977, and A071925 (Exp. 9/30/20);
  • 140-mg temozolomide capsules in 5-count bottles (NDC 67877-540-07) from lots A063581, A063462, and A063460 (Exp. 9/30/19); A063582 (Exp. 10/31/19); A069129 (Exp. 5/31/20); and A071801 (Exp. 9/30/20);
  • 140-mg temozolomide capsules in 14-count bottles (NDC 67877-540-14) from lots A063639, A063624, and A063609 (Exp. 9/30/19); A063657 (Exp. 10/31/19); A069366 (Exp. 5/31/20); and A071817, A071819, and A071818 (Exp. 9/30/20);
  • 180-mg temozolomide capsules in 5-count bottles (NDC 67877-541-07) from lots A061858, A061857, A061856, A061860, and A061859 (Exp. 7/31/19); A069401 and A069402 (Exp. 5/31/20); A071978 (Exp. 9/30/20); and A076736 and A076735 (Exp. 4/30/21);
  • 180-mg temozolomide capsules in 14-count bottles (NDC 67877-541-14) from lots A062031, A062015, A062014, A062050, and A062038 (Exp. 7/31/19); A069521 and A069470 (Exp. 5/31/20); A071979, A072014, and A072013 (Exp. 9/30/20); A076739, A076738, and A076737 (Exp. 4/30/21); and 
  • 250-mg temozolomide capsules in 5-count bottles (NDC 67877-542-07) from lots A062228, A062227, A062226, A062295, and A062294 (Exp. 8/31/19); A069325 and A069323 (Exp. 5/31/20); A072015 (Exp. 10/31/20); and A076611, A076609, A076608, and A076607 (Exp. 4/30/21). 

Deva Holding A.S. voluntarily initiated the recall July 16, 2019. On July 23, 2019, the FDA designated the recall Class II, signaling use of the tablets could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Temozolomide is a prescription oral chemotherapy drug used to treat patients with brain cancer.

Jolynn Tumolo

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