CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED Recall D-0717-2022
Description: TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 Sterile Single-Use Vials per box, Akorn Consumer Health, A Division of Akorn, Inc., Ann Arbor, MI 48105. NDC 58790-010-30
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED Recall D-0717-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0717-2022 |
| Event ID | 89836 |
| Brand | THERATEARS EXTRA |
| Generic Name | CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED |
| Manufacturer | CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED |
| Original Package? | 1 |
| Active Substance | CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED |
| Drug Route | OPHTHALMIC |
| Distribution | Nationwide within theUSA |
| Quantity | 62,331 box |
| Recall Reason | Lack of Assurance of Sterility |
| Drug Classification | Class II |
| Drug Code Info | 20220330 |
| Product NDC | 58790-010 |
| Recall Initiation Date | 20210908 |
| Report Date | 20220330 |
| Classification Date | 20220324 |
| Address | 1925 W Field Ct Ste 300 Lake Forest, IL 60045-4862 United States |
| Recalling Firm | Akorn, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | K679OBS311 |
| Drug Application Number | part349 |
| Structured Product Labeling (SPL ID) | 735d60b9-9999-4e46-827c-abf2a2b70401 |
| Structured Product Labeling (SPL Set ID) | f1845041-9d8d-42a0-a2cb-68def7a5aac7 |
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