DEXTRAN 70 Recall D-1167-2023
Description: octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Each (2X 15 mL Bottles), Manufactured for Innovus Pharmaceuticals, Inc., Englewood, CO 80112, Made in Jordan, NDC:57483-610-15.
DEXTRAN 70 Recall D-1167-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1167-2023 |
| Event ID | 92974 |
| Brand | OCTIQ LUBRICANT EYE DROPS |
| Generic Name | DEXTRAN 70 HYPROMELLOSE |
| Manufacturer | DEXTRAN 70 HYPROMELLOSE |
| Original Package? | 1 |
| Active Substance | DEXTRAN 70 HYPROMELLOSE 2910 (4000 MPA.S) |
| Drug Route | OPHTHALMIC |
| Distribution | Product was distributed to two (2) direct accounts in RI and CO. |
| Quantity | 30,490 units |
| Recall Reason | Lack of Assurance of Sterility |
| Drug Classification | Class II |
| Drug Code Info | 20230927 |
| Product NDC | 57483-610 |
| Product NUI | N0000184175 N0000009361 N0000010288 |
| Pharma Class (PE) | Increased Intravascular Volume [PE] |
| Pharma Class (EPC) | Plasma Volume Expander [EPC] |
| 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 | 7SA290YK68 RN3152OP35 |
| Drug Application Number | part349 |
| Structured Product Labeling (SPL ID) | 3d565185-d750-400a-bcf7-dd6a3d29d282 |
| Structured Product Labeling (SPL Set ID) | 407eeffb-cb32-44bc-aef4-b1b654ac6159 |
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