Drug product
Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408, NDC 50742-308-05.
D-1058-2019
Product summary
- Event
- Event 82401
- Status
- Terminated
- Classification
- Class III
- Quantity
- 29,435 bottles
- Official record key
drug-enforcement:D-1058-2019
Official wording
Reason: Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
Code information: Lot #: 31804, Exp 11/2019; 31911, 31917, Exp 02/2020; 32067, 32072, 32084, Exp 06/2020; 32248, Exp 10/2020
Distribution pattern: Nationwide in the USA and Puerto Rico.
Derived failure modes
-
Unknown
Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.