Recall: D-0092-2019

Class II - Potentially Harmful

Class IIClassification

2018-10-05Initiated

TerminatedStatus

LUPIN SOMERSETFirm

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

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.