Sun Pharma, Lupin Recall Products In US Market, Says USFDA

Leading drugmakers Sun Pharma and Lupin are recalling different products in the US, the world’s largest market for medicines, for different reasons. As per the latest enforcement report by the US Food and Drug Administration (USFDA), Sun Pharma is recalling 22,752 blister packs of Loratadine-D extended-release tablets, used for the treatment of allergic rhinitis and the common cold, in the US market.
According to USFDA, the Mumbai-based drug maker is recalling the affected lot due to “failed moisture limits.” New Jersey-based Sun Pharmaceutical Industries Inc, a unit of the company, has initiated the Class III nationwide (US) recall of the 10-count blister packs on October 12 this year. Lupin, on the other hand, is recalling 16,272 bottles of Gatifloxacin Ophthalmic Solution, an antibiotic used to treat bacterial infections of the eyes. As per USFDA, the company’s US-based unit is recalling the affected lot due to “failed stability specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.” The affected lot has been manufactured at Lupin’s Pithampur-based plant in Madhya Pradesh. The lot has been distributed in the US by Baltimore-based Lupin Pharmaceuticals Inc, the report stated. The drug maker initiated the nationwide (US and Puerto Rico) Class III voluntary recall on November 2 this year. As per USFDA, a Class III recall is initiated in a “situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”
The US generic drug market was estimated to be around USD 115.2 billion in 2019. It is the largest market for pharmaceutical products.

Source: businessworld