12 FDA recalls mention Fluocinonide. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Fluocinonide.
Reason Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Reason Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Reason Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Reason Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
Reason Cross contamination with other products: traces of Dapsone were found in the finished product.
Reason Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of…
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Reason Lack of Processing Controls
Reason Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in…
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