Cromolyn Sodium Oral Solution — Class II drug recall D-0946-2023
Completed recall by The Ritedose Corporation, reported 2023-08-09, distributed nationwide. CGMP deviation: product released prior to supplier approval.
| Recall number | D-0946-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Ritedose Corporation, Columbia, SC, United States |
| Recall initiated | 2023-07-21 |
| Classified | 2023-07-31 |
| Reported by FDA | 2023-08-09 |
| Distributed | Nationwide (US) |
| Quantity | 44 cartons |
| Reason classes | cgmp |
| NDC | 76204-0025-96 |
| Lot numbers | 23CE2 |
| Expiration dates | 2026-03-31 |
Product
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.
Reason for recall
CGMP deviation: product released prior to supplier approval.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0946-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.