New Delhi/Bhopal: Leading generic drug makers Lupin, Sun Pharma and Jubilant Cadista 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), the US-based unit of Lupin is recalling 17,814 bottles of Cefprozil for Oral Suspension USP, a second-generation antibiotic used to treat ear infections, skin infections, and other bacterial infections.
According to the USFDA, the company is recalling the affected lot for being "Superpotent". The affected lot has been manufactured at Lupin's Mandideep plant in Madhya Pradesh and distributed in the US by Baltimore-based Lupin Pharmaceuticals Inc, the report stated. Lupin initiated the Class II voluntary recall across the US and Puerto Rico on March 26 this year.
USFDA further stated that Sun Pharma is recalling 13,834 bottles of diabetes drug Riomet (metformin hydrochloride oral solution) in the US due to "Microbial Contamination of Non-Sterile Product".
The affected lot has been distributed in the US by New Jersey-based Sun Pharmaceutical Industries Inc. The company initiated Class II nationwide recall on March 31 this year.
Similarly, US-based Jubilant Cadista Pharmaceuticals is recalling 12,192 bottles of an antifungal medication Itraconazole Capsules due to "Failed Dissolution Specifications".
The company is a fully-owned subsidiary of Cadista Holdings Inc, which is a part of the Noida-based Jubilant Life Sciences Company.
The affected lot has been produced by Jubilant Generics at its Roorkee based plant in Uttarakhand and marketed in the US by Salisbury-based Jubilant Cadista Pharmaceuticals, Inc.
Jubilant commenced Class II recall in the US on April 1, 2021. As per the USFDA, a 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.
According to industry estimates, the US generic drug market was estimated to be around USD 115.2 billion in 2019.