The reason for the recall is "failed dissolution specifications: the firm was notified that there was a dissolution out of specification result on the 6 month stability samples", as per the latest Enforcement Report of the US Food and Drug Administration (USFDA).
As per the report, the class III ongoing nationwide and Puerto Rico recall for the 20,537 bottles is firm initiated. 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".
Bupropion Hydrochloride extended release tablets USP (XL)in the strength of 300 mg is indicated for the treatment of major depressive disorder.
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