Drug 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
D-0256-2026
Product summary
- Event
- Event 98241
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 24,624 bottles
- Official record key
drug-enforcement:D-0256-2026
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Code information: Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027
Distribution pattern: Nationwide within the USA
Derived failure modes
-
Potency or specification failure
Out of specification