Sun Pharma recalls 31,762 bottles of anti-depressant drug in US
The USFDA has categorized the product recall as class III on account of ‘failed dissolution specifications’
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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.”