Reported Jul 18, 2018 · Terminated
Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT,…
Teva Pharmaceuticals USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals USA · 1090 Horsham Rd · North Wales, PA · 19454-1505
Is this the product you have?
- Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only
- Manufactured byActavis Laboratories UT, Inc., Salt Lake City, UT 84108 USA
- Distributed byActavis Pharmac, Inc., Parsippany, NJ 07054 USA, NDC 0591-2990-60
- Lot codes and dates
Lot #s: 1164898EXP 10/1811649041164909EXP 11/181211396EXP 07/1912308081231127EXP 01/20
- Amount recalled
- 27,803 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.
This product could cause temporary or reversible health problems — stop using it.
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