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
Recall Number: D-0092-2019
Firm: LUPIN SOMERSET
Classification: Class II
Status: Terminated
Report Date: 20181031
Initiation Date: 20181005
Termination Date: 20221108
Reason for Recall
Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
Product Description
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