CROMOLYN SODIUM Recall D-0946-2023
Description: Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules per carton, Rx Only, For Oral Use Only - Not For Inhalation or Injection, Must be Diluted, Manufactured by: The Ritedose Corporation Columbia, SC 29203 for Ritedose Pharmaceuticals, LLC Columbia, SC 29203, NDC 76204-025-96.
CROMOLYN SODIUM Recall D-0946-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0946-2023 |
| Event ID | 92754 |
| Brand | CROMOLYN SODIUM ORAL SOLUTION (CONCENTRATE) |
| Generic Name | CROMOLYN SODIUM ORAL SOLUTION (CONCENTRATE) |
| Manufacturer | CROMOLYN SODIUM ORAL SOLUTION (CONCENTRATE) |
| Original Package? | 1 |
| Active Substance | CROMOLYN SODIUM |
| Drug Route | ORAL |
| Distribution | Nationwide in the US |
| Quantity | 44 cartons |
| Recall Reason | CGMP deviation: product released prior to supplier approval. |
| Drug Classification | Class II |
| Drug Code Info | 20230809 |
| Product NDC | 76204-025 |
| Recall Initiation Date | 20230721 |
| Report Date | 20230809 |
| Classification Date | 20230731 |
| Address | 1 Technology Cir Columbia, SC 29203-9591 United States |
| Recalling Firm | The Ritedose Corporation |
| Initial Notification | |
| Unique Ingredient Identifier | Q2WXR1I0PK |
| Drug Application Number | ANDA209264 |
| Structured Product Labeling (SPL ID) | fed200e2-e17b-af55-e053-6294a90a5752 |
| Structured Product Labeling (SPL Set ID) | d208df15-c823-6e0d-e053-2a95a90ad1be |
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