FDA-Drug2026-01-21Class III

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

SUN PHARMACEUTICAL INDUSTRIES INC
Hazard

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

Sold states
Nationwide within the USA
Affected count
24,624 bottles
Manufactured in
2 Independence Way, Princeton, NJ, United States
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0256-2026

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