LUPIN SOMERSET recalls Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, In
Recalled January 30, 2019 · FDA recall D-0390-2019 · LUPIN SOMERSET
Hazard
Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient. · FDA Class II
Units
24,180 bottles
Sold at
Nationwide in the USA and Puerto Rico
Description
Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient.
Product
Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; NDC 43386-069-60.
Manufacturer(s)
LUPIN SOMERSET
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →