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:
- M008130 – 06/2022
- M008131 – 06/2022
- M008132 – 06/2022
- M008133 – 06/2022
- M010080 – 07/2022
- M010081 – 07/2022
- M011029 – 08/2022
- M011030 – 08/2022
- M011031 – 08/2022
- M011032 – 08/2022
- M011304 – 08/2022
- M013394 – 09/2022
- M013395 – 09/2022
- M013396 – 09/2022
- M013966 – 09/2022
- M013967 – 09/2022
- M100831 – 12/2022
- M100832 – 12/2022
- M100833 – 01/2023
- M100834 – 01/2023
- M101267 – 01/2023
- M102718 – 01/2023
- M102719 – 01/2023
- M102720 – 01/2023
- M102721 – 01/2023
- M102722 – 02/2023
- M104172 – 02/2023
- M104173 – 02/2023
- M104174 – 02/2023
- M104175 – 02/2023
- M104176 – 02/2023
- M105889 – 03/2023
- 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.