New Delhi: Aurobindo Pharma and Cadila Healthcare have recalled over 25,500 bottles of two different drugs in the US due to presence of foreign tablets and failed dissolution specifications.
Aurobindo Pharma USA Inc is recalling 23,016 bottles of Pantoprazole Sodium delayed-release tablets USP, 40 mg as the firm “received a market complaint stating the presence of one foreign tablet (Montelukast Sodium Chewable tab 4mg) in the product bottle of Pantoprazole,” the latest enforcement report on the USFDA website said.
Pantoprazole Sodium delayed-release tablets are used for treatment of erosive inflammation of the esophagus due to acid reflux. The product was manufactured at Aurobindo Pharma’s Mahaboob Nagar plant.
According to the report this is a Class II recall by Aurobindo Pharma. Amerisource Health Services is recalling 2,626 bottles of Bupropion Hydrochloride extended-release tablets USP (XL), 300 mg manufactured by Ahmedabad based Cadila Healthcare.
The recall is due to “failed dissolution specifications—specification result for dissolution was identified during 3 month stability testing,” the enforcement report by the US Food and Drug Administration (USFDA) said.
Cadila Healthcare’s voluntary ongoing Class III recall is nationwide and in Puerto Rico, USFDA said. Bupropion Hydrochloride extended release tablets are used for treatment of major depressive disorder.
The Class II recall is initiated in 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.
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.”