Drug product
Diclofenac Sodium, Topical Gel, 3%, 100 g 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 51672-1363-7
D-0342-2026
Product summary
- Event
- Event 98351
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0342-2026
Official wording
Reason: Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
Code information: Lot # AD92721, Exp Date: 3/31/2027.
Distribution pattern: US Nationwide.
Derived failure modes
-
Potency or specification failure
Out of Specification