Indian pharma firm Lupin pulls back 16,000 bottles of TB drug from US markets over manufacturing defects

Indian pharma firm Lupin pulls back 16,000 bottles of TB drug from US markets over manufacturing defects

The batch pulled down from drug store shelves, was manufactured at Lupin's Aurangabad unit.

FPJ Web DeskUpdated: Saturday, January 21, 2023, 02:36 PM IST
Indian pharma firm Lupin pulls back 16,000 bottles of TB drug from US markets over manufacturing defects
Image: Lupin (Representative)

India-made cough syrups causing deaths in Africa and Uzbekistan, and the USFDA's action against Sun Pharma over lapses at its Halol plant, have badly affected the image of Indian drugmakers. Although an anti-trust lawsuit against Dr Reddy's was dismissed by a US court, another Indian pharma major has been forced to pull back its drugs from American markets. Indian pharma major Lupin has recalled more than 16,000 bottles of its tuberculosis drug Rifampin over possible side effects.

The firm failed to specify impurities, which are supposed to be spotted during substance testing for long term stability. The batch pulled down from drug store shelves, was manufactured at Lupin's Aurangabad unit.

The Class II nationwide recall was initiated on December 12 last year, as it is required when a violative product poses the risk of temporary adverse health effects which are medically reversible, and chances of serious consequences are negligible.