FDA Drug Class III — Least Serious

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

Hazard

Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.

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Products

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
Brand
SUN PHARMACEUTICAL INDUSTRIES INC
UPC
Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027

Units Affected

24,624 bottles

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