Teva Pharmaceuticals USA recalls Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, I
Recalled July 18, 2018 · FDA recall D-0909-2018 · Teva Pharmaceuticals USA
Hazard
Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants. · FDA Class II
Units
27,803 bottles
Sold at
Nationwide in the USA and Puerto Rico
Description
Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.
Product
Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108 USA; Distributed by: Actavis Pharmac, Inc., Parsippany, NJ 07054 USA, NDC 0591-2990-60.
Manufacturer(s)
Teva Pharmaceuticals USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →