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.
Reason for recall: Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.
Recall initiated: 20180705
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated