Lupin is recalling one batch of high blood pressure (BP) tablets --losartan potassium-- from the US market. The drugs with the expiry in July next year are being recalled after they exceeded the permissible impurity level.
Further, as per the US Food and Drug Administration (FDA) enforcement report, the product did not meet specification for impurities at the 9-month stability station. Further, the recall falls under the FDA's Class II category which means that the use of the drug may cause temporary or medically reversible adverse health consequences, but unlikely to have serious adverse health consequences.
The company informed the authorities about the deficiency of the drug made at the company’s Goa facility in the last month and since then the recall is going on. In total there are over 34 thousands bottles in the market.
In June, the company also recalled about 5,000 bottles of BP drug perindopril erbumine tablets from the US market because the drug was subpotent. The drug was also made at the Goa plant. Additionally, in April, the company voluntary recalled a batch of its hypertension drug Lisinopril because of adulterated presence of foreign tablets.
Company Name | CMP |
---|---|
Sun Pharma Inds. | 1808.30 |
Dr. Reddys Lab | 1357.35 |
Cipla | 1467.00 |
Lupin | 2160.45 |
Zydus Lifesciences | 974.65 |
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