Drug product
TRP Stye Relief, 4 g, NDC 17312-014-13
D-0470-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 318,412 units
- Official record key
drug-enforcement:D-0470-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: RHP 8/19 RLD 12/19 SDE 4/20 SID 9/20
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility