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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