Drug major Sun Pharma is recalling over 34,000 bottles of a generic medication, used to treat high blood pressure, in the US market due to failed dissolution testing.
The US division of Sun Pharmaceutical Industries is recalling a large quantity of extended-release capsules containing the drug diltiazem hydrochloride, which is used to treat angina, high blood pressure, and some types of irregular heartbeats.
Princeton (New Jersey) based Sun Pharmaceutical Inc is recalling the affected lot due to "Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory."
The batch was created by the Mumbai-based drug company's Halol-based manufacturing facility in Gujarat. The affected lot was later distributed in the market by the company's US-based subsidiary.
On January 13 of this year, the business announced a Class II countrywide recall (US).
According to the USFDA, a Class II recall is started when using or being exposed to a product that is in violation may result in short-term or medically treatable adverse health effects or when the likelihood of substantial adverse health effects is remote.
With inputs from Agencies.
