FDA (Drugs) recall action 90029
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.
cGMP deviations
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.
Glenmark Pharmaceuticals is recalling 12,003 bottles of Zonisamide 50 mg capsules nationwide due to manufacturing deviations.
Glenmark Pharmaceuticals is recalling Zonisamide Capsules (100 mg) due to current good manufacturing practice (cGMP) deviations. Two lots were distributed nationwide.
Glenmark Pharmaceuticals is voluntarily recalling 11,136 bottles of Zonisamide Capsules due to manufacturing quality control deviations. No illnesses have been reported.