Drug product
TRP Natural Eyes, Stye Relief, Sterile Eye Ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-014-13.
D-1165-2023
Product summary
- Event
- Event 92974
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 180,315 units
- Official record key
drug-enforcement:D-1165-2023
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot:182002 EXP: 11/24; Lot:182003 EXP: 11/24; Lot:182004 EXP: 12/24; Lot:182005 EXP:02/25; Lot:182006 EXP:02/25; Lot:182007EXP:02/25; Lot:182008 EXP:02/25; Lot:182009 EXP:02/25; Lot:182010 EXP:03/25: Lot:182011 EXP:03/25;
Distribution pattern: Product was distributed to two (2) direct accounts in RI and CO.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility