FDA-Drug2018-07-18Class II
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.
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.
Sold states
Nationwide in the USA and Puerto Rico
Affected count
27,803 bottles
Manufactured in
1090 Horsham Rd, North Wales, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0909-2018Don't want to check this manually?
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