FDA (Drugs) recall action 95778
The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
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.
Endo USA recalls 8,029 cartons of Clonazepam 0.125 mg tablets nationwide due to incorrect carton labeling, although the tablets in the blister strips have the correct strength.
Endo USA, Inc. is recalling 22,513 cartons of clonazepam tablets due to incorrect strength labeling on some carton exteriors. The actual tablets inside have correct labeling.
Endo USA is recalling approximately 9,816 cartons of Clonazepam 2 mg tablets due to incorrect strength labeling on the carton exterior. The blister strips inside contain the correct formulation.
Endo USA recalls clonazepam tablets because some cartons are labeled with incorrect declared strength. The medication inside the blister strips contains the correct strength.