Caraco Pharmaceutical Laboratories, a subsidiary of Sun Pharma, has initiated recall of some lots of Venlafaxine Hydrochloride extended-release tablets from the US market.
According to a notification by the FDA, the recall of 26,530 units of 30-count bottles and 14,597 units of 90-count bottles is voluntarily initiated by the company through a letter to the regulator last month under ‘Class-II’ classification.
Venlafaxine Hydrochloride extended-release tablets are indicated for the treatment of major depressive disorder.
“Stability results found the product did not meet the drug release dissolution specifications,” the regulator’s Web site said.
Tablet dissolution is a standardised method for measuring the rate of drug release from a dosage form.
The recalled drug bottles were distributed by Caraco Pharmaceutical Laboratories Ltd in USA, while manufactured at Halol plant in Gujarat by Sun Pharmaceutical Industries Ltd.
According to the US health regulator, Class II recall is a situation in which the 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.
Comments
Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.
We have migrated to a new commenting platform. If you are already a registered user of TheHindu Businessline and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.