Re­call re­port: An­oth­er month, an­oth­er is­sue with ND­MA

It’s been six months since the last in­ci­dent, but 2021 end­ed with the tal­ly re­set­ting back to “ze­ro days.”

Viona Phar­ma­ceu­ti­cals is re­call­ing 33 lots of met­formin hy­drochlo­ride af­ter find­ing traces of ND­MA, a known prob­a­ble hu­man car­cino­gen with can­cer-caus­ing po­ten­tial. It’s a much larg­er re­call than the two lots of 750 mg ex­tend­ed-re­lease tablets it re­called in June.

Met­formin is used to help im­prove glu­cose con­trol in adults with type 2 di­a­betes, and is pack­aged in bot­tles of 100 tablets. The drug can be iden­ti­fied by its cap­sule-shaped, un­coat­ed off-white col­or tablets that fea­ture a “Z” and a “C” on one side and “20” on the oth­er.

The fol­low­ing lots are be­ing re­called:

  1. M008130 – 06/2022
  2. M008131 – 06/2022
  3. M008132 – 06/2022
  4. M008133 – 06/2022
  5. M010080 – 07/2022
  6. M010081 – 07/2022
  7. M011029 – 08/2022
  8. M011030 – 08/2022
  9. M011031 – 08/2022
  10. M011032 – 08/2022
  11. M011304 – 08/2022
  12. M013394 – 09/2022
  13. M013395 – 09/2022
  14. M013396 – 09/2022
  15. M013966 – 09/2022
  16. M013967 – 09/2022
  17. M100831 – 12/2022
  18. M100832 – 12/2022
  19. M100833 – 01/2023
  20. M100834 – 01/2023
  21. M101267 – 01/2023
  22. M102718 – 01/2023
  23. M102719 – 01/2023
  24. M102720 – 01/2023
  25. M102721 – 01/2023
  26. M102722 – 02/2023
  27. M104172 – 02/2023
  28. M104173 – 02/2023
  29. M104174 – 02/2023
  30. M104175 – 02/2023
  31. M104176 – 02/2023
  32. M105889 – 03/2023
  33. M105890 – 03/2023

ND­MA has can­cer-caus­ing po­ten­tial, and is some­times found in meats, dairy prod­ucts and veg­eta­bles. Is­sues with the car­cino­gen have plagued the man­u­fac­tur­ing in­dus­try in the last few years.

Last Jan­u­ary, Nos­trum Lab­o­ra­to­ries twice vol­un­tar­i­ly re­called its gener­ic met­formin. In No­vem­ber 2020, a batch of 500 mg tablets were re­called for the same rea­son.

More re­cent­ly, in June, Pfiz­er yanked its ground­break­ing an­ti-smok­ing drug Chan­tix off of the shelves and halt­ed dis­tri­b­u­tion. June, Ju­ly, Au­gust and Sep­tem­ber all saw lots of the drug re­called by Pfiz­er for con­t­a­m­i­na­tion by ni­trosamine, an­oth­er known car­cino­gen, or ND­MA. Lots were dis­trib­uted in the US, US Vir­gin Is­lands and Puer­to Ri­co from May 2019 to Sep­tem­ber 2021.

Of­fi­cials at Pfiz­er orig­i­nal­ly said the drug­mak­er be­lieved the ben­e­fits of the an­ti-smok­ing drug out­weigh any po­ten­tial risk of ex­po­sure to ni­trosamines or ND­MA, and that those who have been tak­ing it should con­tin­ue to do so. It stuck by that mantra, but a lat­er an­nounce­ment fea­tured ex­ten­sive in­for­ma­tion about how to re­turn the dis­trib­uted batch­es and stop fur­ther dis­tri­b­u­tion.

Since No­vem­ber 2020, there have been two ad­di­tion­al drugs re­called be­cause of re­ports of ND­MA. In 2018, blood pres­sure drug val­sar­tan was pulled for the same rea­son.

Graphic: Alexander Lefterov for Endpoints News

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Alexander Lefterov/Endpoints News

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