Due to failed dissolving testing, drug giant Sun Pharma is recalling over 34,000 bottles of a generic drug used to treat high blood pressure from the US market.
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, hypertension, and some types of irregular heartbeats.
Due to ‘failed impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory,’ Princeton, New Jersey-based Sun Pharmaceutical Inc. is recalling the impacted batch. The batch was created by the Mumbai-based drug company’s Halol-based manufacturing facility in Gujarat. Later, the contaminated lot’s US-based manufacturer dispersed it in the market.
On January 13 of this year, the business announced a Class II countrywide recall (US).
The USFDA reported that, 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.
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