FDA (Drugs) recall action 76282
The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Failed Dissolution Specifications; 18 month stability time point
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Sun Pharmaceutical Industries is recalling specific lots of Bupropion Hydrochloride Extended-release Tablets because they failed dissolution specifications and a 18-month stability time point.
Sun Pharmaceutical Industries is recalling 11,618 bottles of buPROPion Hydrochloride Extended-release Tablets due to failed dissolution specifications and stability issues.