
Why Glenmark, Alembic, Sun Pharma have recalled drugs in US
What's the story
Leading Indian pharmaceutical companies Glenmark, Alembic, and Sun Pharma have announced recalls of certain medications in the United States. The decision comes after concerns over manufacturing issues were raised by the US Food and Drug Administration (FDA). The drugs in question are used for treating heart diseases, high blood pressure, as well as insomnia.
Company 1
Glenmark
Glenmark is recalling its Carvedilol tablets, which are used to treat heart failure, hypertension, and heart attacks. The recall affects multiple strengths of the drug due to the presence of a nitrosamine impurity above acceptable intake levels. Around 55,560 units are being recalled for this reason. Glenmark is also recalling 17,496 bottles of Carvedilol tablets as they contain an impurity above FDA-recommended limits.
Additional recall
A look at the tablets
Along with Carvedilol tablets, Glenmark is recalling 22,656 bottles of Theophylline extended-release tablets (400mg) due to failed dissolution specifications. The company initiated this Class II recall in August this year. A Class II recall is issued when use or exposure to a violative product may cause temporary or medically reversible health consequences.
Company 2, 3
Alembic, Sun Pharma
Alembic is recalling 9,492 bottles of Doxepin Hydrochloride capsules due to impurity concerns. The drug is used for treating insomnia and the recall was initiated on July 25. The USFDA flagged this action in its latest Enforcement Report. Sun Pharmaceutical Industries is recalling 11,328 bottles of Spironolactone Tablets due to aluminum contamination. The drug is used for treating high blood pressure and the recall was initiated on August 5.