LUPIN SOMERSET recalls Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore…

Recall date

October 5, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0092-2019

FDA classification

Class II

Brand / firm

LUPIN SOMERSET

Sold / distributed

Nationwide in the USA

Why it was recalled

Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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