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