Last Updated on October 11, 2024 by The Health Master
Bengaluru: Strides Pharma Inc is recalling over six lakh bottles of blood pressure-lowering drug Losartan Potassium tablets in the US market in multiple strengths due to deviation from standard manufacturing norms, according to a USFDA report.
As per the latest enforcement report by the US Food and Drug Administration (USFDA), the company, which is a unit of Bengaluru-headquartered Strides Pharma Science, is recalling 6,78,829 bottles of the blood pressure-lowering drug in the US market.
An affected lot of tables, in strengths of 25 mg, 50mg, and 100 mg, have been manufactured by Vivimed Life Sciences in a Tamil Nadu-based plant and distributed in the US market by New Jersey-based Strides Pharma Inc.
As per the USFDA, the company has initiated Class II recall due to “CGMP (current good manufacturing practices) deviations”.
AZIDO impurity levels were observed to be above acceptable limits, the US health regulator noted.
As per the USFDA report, Strides Pharma Inc is recalling following as part of the nationwide (US) recall, which the company initiated on May 18 this year:
- 2,00,407 bottles of 25 mg Losartan Potassium tablets,
- 3,81,456 bottles of 50 mg Losartan Potassium tablets,
- 96,966 bottles of 100 mg Losartan Potassium tablets,
As per the USFDA, a class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The US generic drug market was estimated to be around USD 115.2 billion in 2019. It is the largest market for pharmaceutical products.
Strides Pharma Science’s global manufacturing sites are located in India (Chennai, Puducherry and two locations in Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi) and the US (New York).
The company focuses on “difficult to manufacture” products that are sold in over 100 countries.
Drug recall: 2.1 million doses of medicine recalled due to this reason
Drug recall: Over 10,000 bottles of generic Anti-depression Drug recalled
Drug recall: Quinapril HCl recalled due to N-Nitroso-Quinapril Content
Drug recall: Pfizer recalls some batches of Blood Pressure drug due to this reason
Drug recall: Insulin Glargine recalled due to this reason
Moderna recalls thousands of C-19 vaccine doses
Drug alert: 41 out of 1233 samples declared as NSQ in May 2022
Side effects of painkillers: Matter sent to CDSCO
USFDA issues 8 Observations to Panacea Biotec for Baddi Facility
Why has aspirin advice for heart protection changed?
USFDA gives tentative nod to Alembic Pharma for Dasatinib tablets
CDSCO classifies 214 Medical Devices under Medical Devices Rule, 2017
PCI: Pharmacy Council of India is against e-selling of medicines
USFDA gives final approval for Adapalene and Benzoyl Peroxide Topical Gel
FDA Haryana and police raid, consignment of medicines recovered
Latest Notifications regarding Pharmaceuticals
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
