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 Specification; product manufactured using an excipient found to be OOS for conductivity
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
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 Ezetimibe and Simvastatin 10 mg/80 mg tablets because the product was manufactured using an excipient that failed conductivity specifications.
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.