Drug recall D-0909-2018
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.
Lots and codes
Lot #s: 1164898, EXP 10/18; 1164904, 1164909, EXP 11/18; 1211396, EXP 07/19; 1230808, 1231127, EXP 01/20
Recall details
- Recalling firm
- Teva Pharmaceuticals USA, North Wales, PA
- Quantity
- 27,803 bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 5, 2018
- Terminated
- April 3, 2019
Related products
- Fluocinolone Acetonide Topical – drug information
- NDC 0591-2990 Fluocinolone Acetonide Topical · Fluocinolone Acetonide .1 mg/mL · Actavis Pharma, Inc.