LUPIN SOMERSET recalls Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore,
Recalled October 31, 2018 · FDA recall D-0092-2019 · LUPIN SOMERSET
Hazard
Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis · FDA Class II
Units
2712 60-ml bottles
Sold at
Nationwide in the USA
Description
Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
Product
Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, 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 →