FDA (Drugs) recall action 64995
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.
Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature.
Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature.
Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.
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 Generics Inc. is recalling Gabapentin tablets due to complaints of a moldy, musty, or fishy odor. The FDA classifies this as a Class III recall.
Glenmark Generics Inc. is recalling Topiramate Tablets due to complaints of a moldy, musty, or fishy odor. The recall covers 9,624 bottles distributed nationwide.
Glenmark Generics is recalling Pravastatin Sodium 40 mg tablets due to reports of a moldy, musty, or fishy odor.