The recall is due to ‘failed impurities/degradation specifications’
Domestic drug majors Sun Pharmaceutical Industries and Lupin are recalling 41,737 bottles of three drugs used for various ailments such as high blood pressure, depression and anxiety in the US.
Sun Pharmaceutical Industries is recalling 12,109 bottles of Carvediol tablets USP used for treatment of high blood pressure, according to the latest Enforcement Report of the US Food and Drug Administration (US FDA).
The recall covers tablets in strengths of 3.125 mg, 6.25 mg, 12.5 mg and 25 mg in the US in a ongoing voluntary nationwide recall, it added. The recall is due to “failed impurities/degradation specifications,” the report said.
The tablets were manufactured at Hungary-based Alkaloida Chemical Company, which is a subsidiary of Sun Pharma. On the other hand, Lupin is recalling 3,192 bottles of Escitalopram and 26,436 bottles of Lisinopril tablets.
While Escitalopram tablets are used for treatment of depression and anxiety, Lisinopril tablets are indicated for treating hypertension.
The recall of Escitalopram tablets USP in the strength of 20 mg is on account of “Labeling: incorrect or missing lot and/or expiration date,” the report said.
The product was made for Lupin Pharmaceuticals Baltimore by Lupin at its Goa facility.
As per the report, Lupins recall of Lisinopril tablets for strengths of 30 mg and 40 mg is on account of GMP deviations as the finished products were manufactured using active pharmaceutical ingredients, whose intermediates failed specifications.
The product was made at Lupins Pithampur facility, it added.
All the three voluntary ongoing recalls are class III, the enforcement report said.
As per the US FDA, 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.”