FDA-Drug2026-04-22Class II
Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-2.
SUN PHARMACEUTICAL INDUSTRIES INC
Hazard
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Sold states
Nationwide in the USA.
Affected count
41,712 30g tubes
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-2.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0476-2026Original summary
Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-2. Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. Lot# AD76251, Exp Date: 6/30/2026. Distribution: Nationwide in the USA. Affected quantity: 41,712 30g tubes
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