CHELIDONIUM MAJUS Recall D-1159-2023
Description: TRP Natural Eyes, Floaters 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: 17312-098-15.
CHELIDONIUM MAJUS Recall D-1159-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1159-2023 |
| Event ID | 92974 |
| Brand | FLOATERS RELIEF |
| Generic Name | CHELIDONIUM MAJUS, PHYSOSTIGMA VENENOSUM SEED, EUPHRASIA STRICTA,POTASSIUM SULFATE, SODIUM CHLORIDE, PHOSPHORUS, SILICON DIOXIDE, SEPIA OFFICINALIS JUICE |
| Manufacturer | CHELIDONIUM MAJUS, PHYSOSTIGMA VENENOSUM SEED, EUPHRASIA STRICTA,POTASSIUM SULFATE, SODIUM CHLORIDE, PHOSPHORUS, SILICON DIOXIDE, SEPIA OFFICINALIS JUICE |
| Original Package? | 1 |
| Active Substance | CHELIDONIUM MAJUS EUPHRASIA STRICTA |
| Drug Route | OPHTHALMIC |
| Distribution | Product was distributed to two (2) direct accounts in RI and CO. |
| Quantity | 18,171 units |
| Recall Reason | Lack of Assurance of Sterility |
| Drug Classification | Class II |
| Drug Code Info | 20230927 |
| Product NDC | 17312-098 |
| Drug UPC | 0858961001983 |
| 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 | 7E889U5RNN C9642I91WL |
| Structured Product Labeling (SPL ID) | e5d71b98-4eb9-98b2-e053-2995a90aed4f |
| Structured Product Labeling (SPL Set ID) | e5d71b42-a314-8d35-e053-2a95a90a85b4 |
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