Lupin is voluntarily recalling its Metformin Hydrochloride Extended-Release
Tablets USP, 500mg and 1000mg products in the U.S. This recall is being conducted out of an abundance of caution in line with the ongoing interaction with the U.S. Food and Drug Administration on NDMA impurity
levels.
Lupin's U.S. subsidiary Lupin Pharmaceuticals Inc. distributes Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg in the U.S. The company said, 'We believe that the issues identified in the concerned products are addressable and we expect to re-introduce our updated Metformin Hydrochloride Extended-Release Tablet product(s) in the U.S. during the current quarter.'
'We wish to separately clarify that all of the company's Metformin products manufactured and marketed in India have been tested for NDMA levels and have been assessed to be safe for patients and comply with all
relevant regulatory norms. Further, these aforementioned products are part of a completely separate supply chain with respect to their API source, formulation process and manufacturing sites', said the company.