New Delhi: Biocon Inc, part of biotechnology major Biocon, is recalling in the US 5,505 bottles of cholesterol lowering Simvastatin tablets for being sub-potent, according to the USFDA.
The 5,505 bottles of Simvastatin tablets in the strength of 5 mg are being recalled in a firm initiated ongoing recall due to the product being a ‘subpotent drug’, the United States Food and Drug Administration (USFDA) said in its latest Enforcement Report.
The tablets are manufactured by Blu Caribe Dorado for Blu Pharmaceuticals Franklin, it added.
When contacted a Biocon spokesperson told PTI: “The Class III recall for 5 mg tablets of simvastatin pertains to a specific lot manufactured by Blu Caribe (Puerto Rico, USA) for Blu Pharmaceuticals (Kentucky, USA) long before Biocon acquired the simvastatin ANDA from Blu.”
The FDA notified Biocon “as we are the current holders of the ANDA”, she added.
Although as per information on the USFDA site, the recall is ongoing, the Biocon spokespseron said: “Blu has successfully initiated and completed the recall. Biocon has not manufactured and supplied any simvastatin tablets to date.”
The recall is a class III recall, the US health regulator said.
As per the USFDA a class III is initiated in a situation “in which use of, or exposure to, a violative product is not likely to cause adverse health consequences”.