Indian drug companies Lupin, Glenmark and Dr. Reddy’s Laboratories have recalled different products in the US market due to deviation from standard manufacturing norms, according to Devdiscourse.
Lupin is recalling over 3.3 million bottles of losartan potassium pills in the US market, according to the latest enforcement report by the Food and Drug Administration (FDA). The company is also recalling close to 3.9 million bottles of losartan potassium and hydrochlorothiazide pills.
Losartan is used for the treatment of high blood pressure and heart disease.
The FDA said Lupin is recalling the affected lot because of CGMP (current good manufacturing practices) deviations. The Baltimore-based Lupin Pharmaceuticals initiated Class II recall on March 31. The affected lot was manufactured at Lupin’s plant situated in Madhya Pradesh, India.
Mahwah (New Jersey) based Glenmark Pharmaceuticals is recalling over 32,000 bottles of zonisamide capsules in the US market. The medicine is used for the treatment of epilepsy and Parkinson’s disease.
The FDA said a unit of Mumbai-based Glenmark Pharmaceuticals is recalling the affected lot of zonisamide capsules due to “CGMP deviations.” The Indian drugmaker initiated a Class II voluntary recall on April 25.
Princeton (New Jersey) based Dr. Reddy’s Laboratories is recalling 252 blister packs of lansoprazole delayed-release orally disintegrating tablets. The medicine is used to treat peptic ulcer disease, gastroesophageal reflux disease (GERD), and Zollinger–Ellison syndrome.
Dr. Reddy’s is recalling the affected lot due to “failed dissolution specifications,” according to the FDA. The company initiated Class II recall on April 11.
“Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,” says the FDA. In 2019, the US generic drug market was estimated to be more than $115 billion.