Homegrown pharma biggies Lupin Ltd, Glenmark Pharmaceuticals Ltd and Natco Pharma Ltd have started recalling a host of products from the US markets, according to the latest Enforcement Report by the US Food and Drug Administration.
Lupin is recalling 26,352 bottles of Rifampin capsules, used in the treatment of all forms of tuberculosis, in the US market because it was identified to be a sub-potent drug.
The drug was manufactured in Lupin’s Aurangabad plant in India and was sold by the US arm of Lupin. The recall was initiated on March 21. This was a Class II recall according to the US FDA.
Glenmark recalled 6,528 bottles of Diltiazem Hydrochloride capsules used in the treatment of high blood pressure. The product was manufactured in India and sold by the US arm of Glenmark. The product “failed dissolution specifications”, according to the US FDA. The Class II recall was initiated on March 26.
Natco Pharma recalled 30 bottles of Lansoprazole capsules used in the treatment of gastritis in the US. The product was manufactured in Natco’s plant in Kothur, India and recalled on 27 March. The product was recalled due to Current Good Manufacturing Practice (CGMP) deviations. This was a Class II recall according to the US FDA.
A Class II recall is where the use of, or exposure to the product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote, according to the US FDA.
Indian companies supply 20 percent of the world’s pharma generics, 60 percent of global vaccines and 40 percent of the medicines in the US, according to the Indian Pharmaceutical Association.
Also read: Indian pharmaceutical market registers 9.5% growth in March
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