FDA Drug recall D-0946-2023
Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules per carton, Rx Only, For Oral Use Only - Not For Inhalation or I…
- FDA Drug
- Class II
- completed
- Published 2023-08-09
On 2023-08-09 the FDA classified a Class II recall of Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules per carton, Rx Only, For Oral Use Only - Not For Inhalation or I… by The Ritedose, citing CGMP deviation: product released prior to supplier approval.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0946-2023 |
| Classification | Class II |
| Status | completed |
| Initiated | 2023-07-21 |
| Published | 2023-08-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | The Ritedose |
| Distribution | US |
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
CGMP deviation: product released prior to supplier approval.
Identifiers
| code_info | Lot: 23CE2, Exp. 03/31/2026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0946-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.