The Mumbai-based drug major had produced the lot at its Halol-based manufacturing facility in Gujarat. The affected lot was later distributed in the market by its US-based unit.
New Delhi: 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. As per the US Food and Drug Administration’s Enforcement Report, 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 some types of irregular heartbeats.
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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 Mumbai-based drug major had produced the lot at its Halol-based manufacturing facility in Gujarat. The affected lot was later distributed in the market by its US-based unit. The company initiated the Class II nationwide recall (US) on January 13 this year.
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As per 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.
