FDA (Drugs) recall action 88866
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 Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity
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.
Golden State Medical Supply Inc. is recalling specific lots of Ezetimibe and Simvastatin 10 mg/40 mg tablets because an excipient used in manufacturing failed to meet conductivity specifications, and some bottles were found to contain foreign tablets.
Golden State Medical Supply Inc. is recalling Ezetimibe and Simvastatin 10 mg/80 mg tablets because the product was manufactured using an excipient that failed conductivity specifications.