Strides Pharma recalls over 6 lakh bottles of blood pressure treatment tablets in the US

The affected batch of antihypertensive tablets was manufactured by Vivimed Life Sciences at a factory in Tamil Nadu.

The affected batch of antihypertensive tablets was manufactured by Vivimed Life Sciences at a factory in Tamil Nadu.

Strides Pharma Inc. is recalling more than six lakh bottles of antihypertensive drug Losartan Potassium tablets from the US market in multiple strengths due to a deviation from standard manufacturing standards, according to a USFDA report.

According to the latest US Food and Drug Administration (USFDA) law enforcement report, the company, which is a unit of Bengaluru-headquartered Strides Pharma Science, is recalling 6,78,829 bottles of the drug antihypertensive in the US market.

The affected batch of tables, in 25mg, 50mg and 100mg strengths, were manufactured by Vivimed Life Sciences at a facility based in Tamil Nadu and distributed in the US market by New Jersey-based Strides Pharma Inc.

According to the USFDA, the company initiated the Class II recall due to “CGMP (current good manufacturing practice) deviations”.

Observed AZIDO impurity levels are above acceptable limits, the US health regulator noted.

According to USFDA report, Strides Pharma Inc recalls 2,00,407 bottles of 25mg tablets of losartan potassium, 3,81,456 bottles of 50mg tablets and 96,966 bottles of 100mg tables, as part of national recall (United States), which the company launched on May 18 of this year.

According to the USFDA, a Class II recall is initiated in a situation where use of or exposure to an offending product may result in temporary or medically reversible adverse health consequences or when the likelihood of serious adverse health consequences health is low.

The US generic drug market was estimated at around $115.2 billion in 2019. It is the largest pharmaceutical market.

Strides Pharma Science’s global manufacturing sites are located in India (Chennai, Pondicherry and two sites in Bangalore), Singapore, Italy (Milan), Kenya (Nairobi) and USA (New York).

The company focuses on “hard-to-make” products that are sold in over 100 countries.

About Margie Peters

Check Also

VAXART, INC. Management’s Discussion and Analysis of Financial Condition and Results of Operations (Form 10-Q)

The following discussion and analysis of our financial condition and results of operations should be …