CALENDULA OFFICINALIS FLOWERING TOP Recall D-1151-2023
Description: TRP Natural Eyes, Aging Eye Relief, 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: 17312-027-15.
CALENDULA OFFICINALIS FLOWERING TOP Recall D-1151-2023 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-1151-2023 |
Event ID | 92974 |
Brand | AGINGEYE RELIEF |
Generic Name | TRIBASIC CALCIUM PHOSPHATE, CALENDULA OFFICINALIS FLOWERING TOP, CARBON DISULFIDE, JACOBAEA MARITIMA, CONIUM MACULATUM FLOWERING TOP, EUPHRASIA STRICTA, SELENIUM, ZINC |
Manufacturer | TRIBASIC CALCIUM PHOSPHATE, CALENDULA OFFICINALIS FLOWERING TOP, CARBON DISULFIDE, JACOBAEA MARITIMA, CONIUM MACULATUM FLOWERING TOP, EUPHRASIA STRICTA, SELENIUM, ZINC |
Original Package? | 1 |
Active Substance | CALENDULA OFFICINALIS FLOWERING TOP CARBON DISULFIDE |
Drug Route | OPHTHALMIC |
Distribution | Product was distributed to two (2) direct accounts in RI and CO. |
Quantity | 8,747 units |
Recall Reason | Lack of Assurance of Sterility |
Drug Classification | Class II |
Drug Code Info | 20230927 |
Product NDC | 17312-027 |
Drug UPC | 0858961001273 |
Recall Initiation Date | 20230901 |
Report Date | 20230927 |
Classification Date | 20230915 |
Address | Building 108Street A3, King Abdullah Ii Industrial City Amman, Jordan |
Recalling Firm | AMMAN PHARMACEUTICAL INDUSTRIES |
Initial Notification | Letter |
Unique Ingredient Identifier | 18E7415PXQ S54S8B99E8 |
Structured Product Labeling (SPL ID) | f4c5422c-356b-8fcf-e053-2995a90ae0d9 |
Structured Product Labeling (SPL Set ID) | 5714461b-a266-49c7-88e1-9449d3b4e554 |
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