New Delhi: Drug company Sun Pharma is recalling more than 34,000 bottles of a generic drug used to treat high blood pressure from the US market due to poor dilution tests. The US-based arm of Sun Pharmaceutical Industries is recalling lots of diltiazem hydrochloride extended-release capsules, which are used to treat angina, high blood pressure and certain types of irregular heartbeat, according to an enforcement report by the US Food and Drug Administration. is done for
Princeton (New Jersey)-based Sun Pharmaceutical Inc. is recalling affected lots due to “failed impurity (decetyl diltiazem hydrochloride) specification during stability testing and failed dissolution testing in an FDA laboratory.”
The Mumbai-based drug major had produced the bulk at its Halol-based manufacturing facility in Gujarat. The affected lots were later distributed to the market by its US-based entity. The company initiated the Class II nationwide recall (US) on January 13 this year.
According to the USFDA, a Class II recall is initiated in a situation in which use of or exposure to an infringing product may cause temporary or medically adverse health consequences or where there is a remote likelihood of serious adverse health consequences. it occurs.