CROMOLYN SODIUM Recall D-0137-2023
Description: Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-291-11
CROMOLYN SODIUM Recall D-0137-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0137-2023 |
| Event ID | 90948 |
| Brand | CROMOLYN SODIUM |
| Generic Name | CROMOLYN SODIUM |
| Manufacturer | CROMOLYN SODIUM |
| Original Package? | 1 |
| Active Substance | CROMOLYN SODIUM |
| Drug Route | OPHTHALMIC |
| Distribution | Nationwide in the USA |
| Quantity | 188,550 bottles |
| Recall Reason | CGMP Deviations: |
| Drug Classification | Class II |
| Drug Code Info | 20230125 |
| Product NDC | 17478-291 |
| Drug UPC | 0317478291114 |
| Recall Initiation Date | 20221013 |
| Report Date | 20230125 |
| Classification Date | 20230113 |
| Address | 5605 Centerpoint Ct Ste A Gurnee, IL 60031-5278 United States |
| Recalling Firm | Akorn, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | Q2WXR1I0PK |
| Drug Application Number | ANDA074706 |
| Structured Product Labeling (SPL ID) | 2c91e02d-0a38-4225-b30d-249fd182568f |
| Structured Product Labeling (SPL Set ID) | e604ed4d-d8a7-4f65-a386-b4bd6137d987 |
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