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.