FDA (Drugs) recall action 98856
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.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
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 Primidone 250 mg tablets due to cross-contamination with trace amounts of Acemetacin API. The affected lots are distributed nationwide.
Golden State Medical Supply Inc. is recalling Primidone 50 mg tablets due to cross-contamination of the active pharmaceutical ingredient with trace amounts of Acemetacin API. The recall affects 8,526 bottles distributed nationwide.