Three leading Indian pharmaceutical companies, Lupin Ltd, Glenmark Pharmaceuticals Ltd, and Natco Pharma Ltd, have commenced recalls of numerous products from the US markets, as disclosed in the latest Enforcement Report by the US Food and Drug Administration (FDA).
Lupin’s recall pertains to 26,352 bottles of Rifampin capsules, a vital treatment for various forms of tuberculosis in the US. The decision to recall was prompted by the identification of sub-potency concerns. Manufactured at Lupin’s Aurangabad facility in India and distributed by its US arm, the recall process commenced on March 21, classified as a Class II recall by the US FDA.
Glenmark Pharmaceuticals initiated a recall of 6,528 bottles of Diltiazem Hydrochloride capsules, utilized in managing high blood pressure. The product, manufactured in India, fell short of dissolution specifications, prompting the recall action. Distributed by Glenmark’s US subsidiary, the recall was instigated on March 26 and also categorized as Class II by the US FDA.
Natco Pharma’s recall involves 30 bottles of Lansoprazole capsules, prescribed for gastritis treatment in the US. Manufactured at Natco’s Kothur plant in India, the recall was triggered by deviations from Current Good Manufacturing Practice (CGMP) standards. The recall process, classified as Class II by the US FDA, commenced on March 27.
These recall actions underscore the proactive measures undertaken by these pharmaceutical giants to ensure the safety and quality of their products in the US market.
In accordance with the US Food and Drug Administration (FDA), a Class II recall signifies a scenario where the use or exposure to the product might result in temporary or medically reversible adverse health effects, with the likelihood of serious adverse health consequences being remote.
Indian pharmaceutical firms are pivotal players in the global healthcare landscape, supplying 20 percent of the world’s pharmaceutical generics, 60 percent of global vaccines, and 40 percent of medicines in the US, as per data from the Indian Pharmaceutical Association.