FDA (Drugs) recall action 98677
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 Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
The agency’s own wording, quoted from the enforcement report.
Taro is recalling one lot of Fluocinonide 0.05% Cream in 60 g tubes after stability testing returned viscosity results above the specification limit. 2,640 tubes are affected.
Taro is recalling one lot of Fluocinonide 0.05% Cream in 30 g tubes after stability testing returned viscosity results above the specification limit. 41,712 tubes are affected.
Taro is recalling one lot of Fluocinonide 0.05% Cream after stability testing returned out-of-specification viscosity results above the specification limit. 24,672 tubes are affected.