WATER Recall D-1315-2022
Description: Eye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box, Alcon, NDC 0065-0530-04.
WATER Recall D-1315-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1315-2022 |
| Event ID | 90553 |
| Brand | EYE STREAM |
| Generic Name | PURIFIED WATER |
| Manufacturer | PURIFIED WATER |
| Original Package? | 1 |
| Active Substance | WATER |
| Drug Route | OPHTHALMIC |
| Distribution | Nationwide in the USA. |
| Quantity | 16 boxes |
| Recall Reason | CGMP Deviations: products were stored outside the drug label specifications. |
| Drug Classification | Class II |
| Drug Code Info | 20220817 |
| Product NDC | 0065-0530 |
| Recall Initiation Date | 20220629 |
| Report Date | 20220817 |
| Classification Date | 20220805 |
| Address | 9954 Maryland DriveDeep Run Iii Ste. 4000 Richmond, VA 23233 United States |
| Recalling Firm | Mckesson Medical-Surgical Inc. Corporate Office |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 059QF0KO0R |
| Drug Application Number | part349 |
| Structured Product Labeling (SPL ID) | b61b61a6-aea9-463b-90ca-c683fea1104c |
| Structured Product Labeling (SPL Set ID) | ff9560df-d834-57a8-37b0-3f10e82f5a5d |
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