FDA-Drug2018-10-31Class II
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
LUPIN SOMERSET
Hazard
Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
Sold states
Nationwide in the USA
Affected count
2712 60-ml bottles
Manufactured in
400 Campus Dr, N/A, Somerset, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0092-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief