APIS MELLIFERA Recall D-1164-2023
Description: TRP Natural Eyes, Red Eye 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: 17312-095-19.
APIS MELLIFERA Recall D-1164-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1164-2023 |
| Event ID | 92974 |
| Brand | RED EYE RELIEF PF |
| Generic Name | APIS MELLIFERA, EUPHRASIA STRICTA, CALCIUM SULFIDE, LOESELIA MEXICANA WHOLE, PULSATILLA VULGARIS |
| Manufacturer | APIS MELLIFERA, EUPHRASIA STRICTA, CALCIUM SULFIDE, LOESELIA MEXICANA WHOLE, PULSATILLA VULGARIS |
| Original Package? | 1 |
| Active Substance | APIS MELLIFERA CALCIUM SULFIDE |
| Drug Route | OPHTHALMIC |
| Distribution | Product was distributed to two (2) direct accounts in RI and CO. |
| Quantity | 196,442 units |
| Recall Reason | Lack of Assurance of Sterility |
| Drug Classification | Class II |
| Drug Code Info | 20230927 |
| Product NDC | 17312-095 |
| Product NUI | N0000185021 N0000175629 N0000184306 |
| Drug UPC | 0858961001952 |
| 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 | 7S82P3R43Z 1MBW07J51Q |
| Structured Product Labeling (SPL ID) | f55151c9-5eb2-44f7-e053-2a95a90a8472 |
| Structured Product Labeling (SPL Set ID) | e5d7debd-4caf-d611-e053-2a95a90ad458 |
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