FDA (Drugs) recall action 88798
The FDA (Drugs) publishes a recall like this one as 5 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 5 pages.
Failed Excipient Specifications; 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.
Dr. Reddy's Laboratories is recalling Ezetimibe and Simvastatin Tablets (10 mg/80 mg) because the product was manufactured using an excipient that failed to meet conductivity specifications.
Dr. Reddy's Laboratories is recalling Ezetimibe and Simvastatin Tablets (10 mg/20 mg) nationwide because the product was manufactured using an excipient that failed conductivity specifications.
Dr. Reddy's Laboratories is recalling Ezetimibe and Simvastatin 10 mg/40 mg tablets because an excipient used in manufacturing failed conductivity specifications. The recall affects 11,590 bottles of 30-count and 3,585 bottles of 90-count packages distributed nationwide.
Dr. Reddy's Laboratories is recalling 696 bottles of Ezetimibe and Simvastatin Tablets (10 mg/40 mg) distributed nationwide due to failed excipient specifications and the presence of foreign tablets in bottles.
Dr. Reddy's Laboratories is recalling Ezetimibe and Simvastatin 10 mg/10 mg tablets nationwide because the product was manufactured using an excipient that failed to meet conductivity specifications.