FDA (Drugs) recall action 69928
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: Product failed a known impurity specification.
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.
Micro Labs USA Inc. is recalling specific lots of Simvastatin Tablets, 20mg, because the product failed a known impurity specification.
Micro Labs USA Inc. is recalling 13,464 bottles of Simvastatin 80mg tablets because the product failed a known impurity specification.
Micro Labs USA Inc. is recalling Simvastatin Tablets, 40mg, because the product failed a known impurity specification. The recall affects 13,488 bottles distributed nationwide.