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
Recall initiated: 20181005
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated