Sun Pharma recalls 31,762 bottles of antidepressant drug in US
New Delhi : Sun Pharmaceutical Industries is recalling 31,762 bottles of bupropion hydrochloride extended release tablets used for treatment of major depressive disorder in the US due to 'failed dissolution specifications'.
The recall has been initiated by Sun Pharmaceutical Industries Inc for 31,762 bottles of bupropion hydrochloride extended-release tablets, USP (SR) in the strength of 150 mg, the US Food and Drug Administration (USFDA) said in its latest Enforcement Report.
The tablets have been manufactured by Sun Pharma at its Halol plant.
The ongoing nationwide recall is on account of "failed dissolution specifications," the report said, adding that it is a class III recall.
As per the USFDA, a class III recall is initiated in a situation "in which use of or exposure to a violative product is not likely to cause adverse health consequences."
Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd