Pharma major Lupin is recalling about 5000 bottles each of the blood pressure drug perindopril erbumine from the US market. However, the recall is classified under the class III category which means the use of the medicine is unlikely to cause any adverse impact to patients.
Lupin Pharmaceutical, U.S. wholly owned subsidiary of Lupin, though received final approval from the U.S. Food and Drug Administration (U.S. FDA) for its Perindopril Er umine tablets, 2mg, 4mg and 8mg on January 28, 2011 but later U.S. FDA in its enforcement report has stated that, “The product failed to meet assay results at the 12 month long term stability test point”. Hence the company is recalling, 4962 bottles each containing 100 tablets of perindopril erbumine 2mg tablets.
Lupin's Perindopril Erbumine tablets are AB-rated to ACEON tablets indicated for the treatment of patients with essential hypertension and can be used with conventional treatment for management of coronary artery disease. ACEON had annual sales of approximately $24 million for the twelve months ended September 2009, based on IMS Health sales data.
Company Name | CMP |
---|---|
Sun Pharma Inds. | 1808.50 |
Dr. Reddys Lab | 1342.45 |
Cipla | 1472.45 |
Lupin | 2147.55 |
Zydus Lifesciences | 973.90 |
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