ALLIUM CEPA WHOLE Recall D-1153-2023
Description: TRP Natural Eyes, Allergy 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: 17312-097-19.
ALLIUM CEPA WHOLE Recall D-1153-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1153-2023 |
| Event ID | 92974 |
| Brand | ALLERGY EYES RELIEF PF |
| Generic Name | ALLIUM CEPA, AMBROSIA, APIS, EUPHRASIA, HISTAMINE HYDROCHLORICUM, SABADILLA, SULPHUR |
| Manufacturer | ALLIUM CEPA, AMBROSIA, APIS, EUPHRASIA, HISTAMINE HYDROCHLORICUM, SABADILLA, SULPHUR |
| Original Package? | 1 |
| Active Substance | ALLIUM CEPA WHOLE AMBROSIA ARTEMISIIFOLIA |
| Drug Route | OPHTHALMIC |
| Distribution | Product was distributed to two (2) direct accounts in RI and CO. |
| Quantity | 8,810 units |
| Recall Reason | Lack of Assurance of Sterility |
| Drug Classification | Class II |
| Drug Code Info | 20230927 |
| Product NDC | 17312-097 |
| Product NUI | N0000185021 N0000175629 N0000184306 |
| Drug UPC | 0858961001976 |
| Pharma Class (PE) | Increased Histamine Release [PE] |
| Pharma Class (EPC) | Standardized Insect Venom Allergenic Extract [EPC] |
| Pharma Class (CS) | Allergens [CS] |
| 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 | 8P2VLG2456 9W34L2CQ9A |
| Structured Product Labeling (SPL ID) | f5516d22-738c-40df-e053-2995a90ad4c3 |
| Structured Product Labeling (SPL Set ID) | e5bd53c1-8174-7b0c-e053-2995a90ac115 |
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