New Jersey-based Bayshore Pharmaceuticals has recalled two lots of the extended-release metformin tablets manufactured by Beximco Pharmaceuticals, after finding high levels of a probable carcinogen in the drug samples.
Metformin is the first-line medication for the treatment of type 2 diabetes, particularly in people who are overweight, reports bdnews24.com.
It came after the US Food and Drug Administration found unacceptable levels of N-Nitrosodimethylamine (NDMA) in one lot of metformin hydrochloride extended-release tablets, USP 750 mg, and recommended its withdrawal.
Out of the “abundance of caution”, Bayshore said it had tested samples from eight lots manufactured using the same active pharmaceutical ingredient of the failed lot, according to a company announcement.
From the eight lots, one of 750 mg tablets and one lot of 500 mg tablets have shown NDMA levels in excess of the acceptable daily intake limit, prompting Bayshore to recall the two lots.
NDMA is classified as a probable human carcinogen, a substance that could cause cancer, based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.
To date, neither Bayshore nor Beximco have received any reports of adverse events related to use of the product.
The Directorate General of Drug Administration in Bangladesh said it took samples from 19 companies that produce the drug in the country.
The DGDA was preparing to send the samples to a lob in Singapore for testing, said the directorate’s Assistant Director Ayub Hossain.
WHAT BEXIMCO SAYS
In an emailed response to bdnews24.com, Beximco mentioned a number of drugs that were recalled by the manufacturers for NDMA found above the approved level.
“As a responsible company we also recalled our ranitidine products in Bangladesh, even before it was alerted by our local regulatory authority,” Rabbur Reza, chief operating officer of Beximco Pharmaceuticals, said.
When the FDA alert on metformin was made in June 2020, Beximco started testing all new lots produced for NDMA levels before release, he said.
In addition, the firm started testing the lots marketed in the US over the last two years and found two lots “marginally above” the FDA’s limit of NDMA, Reza said.
“We immediately informed this to FDA and our distribution partner in the US, Bayshore Pharmaceuticals. Then, these two lots were recalled from market on August 19, 2020,” he added.
Beximco started identifying the root cause of NDMA contamination in metformin formulation when the issue emerged, according to Reza.
Citing scientists, he said the problem is not related to their formulation or manufacturing process but “highly likely to be linked to API or its manufacturing process”.
Beximco does not manufacture metformin API or active pharmaceutical ingredient and source this from a different manufacturer, according to him.
The company has now asked its API manufacturer to declare NDMA level of each lot.
According to experts, Reza said, this could be due to contamination from API synthesis, improper solvents or breakdown of unstable drug compounds.
Asked why Bangladeshis should feel confident about safety of Beximco drugs after this recall, Reza said: “We, as a responsible and globally accredited manufacturer, always take proactive measures to ensure quality and safety of products. We continue to work with our global network of API suppliers to make sure our APIs strictly conform to global quality standards.”
