CALCIUM SULFATE ANHYDROUS Recall D-1157-2023
Description: TRP Natural Eyes, Eye Lid 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: 17312-417-19.
CALCIUM SULFATE ANHYDROUS Recall D-1157-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1157-2023 |
| Event ID | 92974 |
| Brand | EYE LID RELIEF PF |
| Generic Name | SILVER, CALCIUM SULFATE ANHYDROUS, CLEMATIS RECTA, EUPHRASIA STRICTA, SUS SCROFA ADRENAL GLAND, GRAPHITE, GOLDENSEAL |
| Manufacturer | SILVER, CALCIUM SULFATE ANHYDROUS, CLEMATIS RECTA, EUPHRASIA STRICTA, SUS SCROFA ADRENAL GLAND, GRAPHITE, GOLDENSEAL |
| Original Package? | 1 |
| Active Substance | CALCIUM SULFATE ANHYDROUS CLEMATIS RECTA FLOWERING TOP |
| Drug Route | OPHTHALMIC |
| Distribution | Product was distributed to two (2) direct accounts in RI and CO. |
| Quantity | 8,000 units |
| Recall Reason | Lack of Assurance of Sterility |
| Drug Classification | Class II |
| Drug Code Info | 20230927 |
| Product NDC | 17312-417 |
| Drug UPC | 0850046938177 |
| 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 | E934B3V59H 396421SP9F |
| Structured Product Labeling (SPL ID) | 00c66fb8-85f9-cbf4-e063-6394a90a0fc2 |
| Structured Product Labeling (SPL Set ID) | 00c675e3-6e9c-dd8d-e063-6294a90ad8c1 |
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