Sun Pharma recalls 34,000 bottles of its generic high blood pressure medicine, in US

13 Feb 2023 , 03:37 PM

Sun Pharma Industries Limited informed that it is recalling more than 34,000 bottles of generic medication in the US market due to failed dissolution testing. This medicine is used to treat high blood pressure. 

According to the US Food and Drug Administration's Enforcement Report, Sun Pharmaceutical Industries' US-based arm is recalling large quantities of Diltiazem Hydrochloride extended-release capsules, which are used to treat angina, some types of irregular heartbeats, and high blood pressure.

The pharmaceutical company located in New Jersey has taken the decision to recall a specific batch of their product due to a failure in impurity control (Deacetyl Diltiazem Hydrochloride) during stability tests, as well as subpar results in dissolution testing as determined by the USFDA’s laboratory.

The lot was manufactured at the Mumbai-based drugmaker's Halol-based manufacturing facility in Gujarat. The affected lot was later supplied in the market by the company's US-based subsidiary.

On January 13, this year, the company began the Class II nationwide recall (US).

The USFDA explains that a Class II recall is called into action when a product that violates their standards may result in health problems that can be fixed with medical intervention, or when the likelihood of severe health consequences is low.

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