Drug product
Fluocinonide, USP, 0.05% Cream, 15g 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 51672-1386-1
D-0475-2026
Product summary
- Event
- Event 98677
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 24,672 15 g tubes
- Official record key
drug-enforcement:D-0475-2026
Official wording
Reason: Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Code information: Lot# AD76252, Exp Date: 6/30/2026.
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Out of Specification