FDA (Drugs) recall action 95098
The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
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 31,802 bottles of IBU Ibuprofen 600mg tablets due to failed impurity specifications. The product was distributed nationwide and in Puerto Rico.
Dr. Reddy's Laboratories is recalling IBU (Ibuprofen) 800 mg prescription tablets nationwide due to failed quality specifications. Testing found unknown impurities exceeding acceptable limits.
Dr. Reddy's Laboratories is recalling IBU Ibuprofen 400 mg prescription tablets due to impurity levels exceeding specifications. The recall affects 14,940 bottles distributed nationwide in the USA and Puerto Rico.