FDA (Drugs) recall action 76122
The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.
Failed Dissolution Specifications; 18 month stability time point
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.
Dr. Reddy's is recalling Flucanazole tablets that failed dissolution and stability specifications. Patients should stop using the affected lots and consult their healthcare provider.
Dr. Reddy's Laboratories is recalling Flucanazole 200 mg tablets nationwide due to failed dissolution specifications and stability issues.
Dr. Reddy's Laboratories is recalling Flucanazole 150 mg tablets because they failed dissolution specifications and 18-month stability testing.
Dr. Reddy's Laboratories is recalling Flucanazole tablets because they failed dissolution and stability specifications.