FDA (Drugs) recall action 83434
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
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.
Alvogen, Inc. is recalling 4,272 bottles of Macrobid (nitrofurantoin monohydrate/macrocrystalline) 100 mg tablets because they failed dissolution specifications.
Alvogen, Inc. is recalling 2,784 bottles of Nitrofurantoin Monohydrate/Macrocrystalline capsules because they failed to meet dissolution specifications.