Topics
Sun Pharma | United States | drugs
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."
').insertAfter(".article-content__img");$(".article-content__img div").find('div').remove();
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.
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.
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.
(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
Exclusive Stories, Curated Newsletters, 26 years of Archives, E-paper, and more!
First Published: Sat, February 11 2023. 14:55 IST
Monzo is preparing a renewed push to secure a US banking licence, four years after abandoning its first attempt when tal... Read more
America’s cryptocurrency companies are scrambling to secure a foothold in the country’s traditional banking system, ... Read more
Parallel Banking: How Stablecoins Are Building a New Global Payments SystemStablecoins—digital currencies pegged to tr... Read more
JPMorgan has deployed an AI-based research analyst chatbot to enhance productivity among its workforce, with approximate... Read more
Private equity has emerged as a significant force in the global financial landscape, driving substantial growth and inve... Read more
The world’s leading financial stability watchdog has issued a warning about the unresolved vulnerabilities within the ... Read more
