Drug product
TRP Natural Eyes, Red Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-095-19.
D-1164-2023
Product summary
- Event
- Event 92974
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 196,442 units
- Official record key
drug-enforcement:D-1164-2023
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: IW001 EXP:07/24; Lot: IW002 EXP: 12/24
Distribution pattern: Product was distributed to two (2) direct accounts in RI and CO.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility