Class III Recall

SUN PHARMACEUTICAL INDUSTRIES INC

Product
Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4
Reason
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Classification
Class III
Status
Ongoing
Lot
Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
SUN PHARMACEUTICAL INDUSTRIES INC — Class III Recall | MedicineWatch US