WATER Recall D-0447-2020
Description: OCuSOFT Eye Wash Sterile Isotonic Buffered Solution, 1 FL OZ (30 mL), Manufactured for OCuSOFT, Inc. Richmond, TX 77406-0429, NDC 54799-565-01
WATER Recall D-0447-2020 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0447-2020 |
| Event ID | 83265 |
| Brand | PURIFIED WATER |
| Generic Name | PURIFIED WATER |
| Manufacturer | PURIFIED WATER |
| Original Package? | 1 |
| Active Substance | WATER |
| Drug Route | OPHTHALMIC |
| Distribution | U.S.A. Nationwide |
| Quantity | 55,134 units |
| Recall Reason | Lack of Assurance of Sterility |
| Drug Classification | Class II |
| Drug Code Info | 20191127 |
| Product NDC | 54799-565 |
| Recall Initiation Date | 20190702 |
| Report Date | 20191127 |
| Classification Date | 20191115 |
| Address | 311 W LnPO Box 849 Aquebogue, NY 11931-0849 United States |
| Recalling Firm | Altaire Pharmaceuticals, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Unique Ingredient Identifier | 059QF0KO0R |
| Drug Application Number | part349 |
| Structured Product Labeling (SPL ID) | c432aeb1-0e26-4893-98b0-7a225a040f26 |
| Structured Product Labeling (SPL Set ID) | 778eb611-5708-a749-e87b-9d80725a5aca |
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