Lupin is voluntarily recalling all batches of Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg products to the consumer level 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’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.
Lupin is an innovation led transnational pharmaceutical company headquartered in Mumbai, India.
