FDA recall D-0092-2019

LUPIN SOMERSET · Class II · drug

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

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2018-10-05
Report date: 2018-10-31
Termination date: 2022-11-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Somerset, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0092-2019