Drug product
TRP Natural Eyes, Dryness 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: 17312-096-19.
D-1156-2023
Product summary
- Event
- Event 92974
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 83,898 units
- Official record key
drug-enforcement:D-1156-2023
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: FR001 EXP: 07/24; Lot: FR004 EXP: 04/25; Lot:FR005 EXP: 04/25; Lot:FR006 EXP: 04/25; Lot: FR007 Exp: 04/25
Distribution pattern: Product was distributed to two (2) direct accounts in RI and CO.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility