FDA (Drugs) recall action 90610
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.
Failed Dissolution Specifications
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.
Jubilant Cadista is recalling 9,600 bottles of Irbesartan Tablets (150mg) nationwide due to failed dissolution specifications. Affected lot IB220023A expires 08/2022.
Jubilant Cadista Pharmaceuticals is recalling 28,560 bottles of Irbesartan 75 mg tablets nationwide due to failed dissolution specifications that may compromise drug efficacy.