Drug recall
Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules per carton, Rx Only, For Oral Use…
FDA recall event 92754 · Class II · The Ritedose Corporation
Key facts
| Event ID | 92754 |
|---|---|
| Recall numbers | D-0946-2023 |
| Recalling firm | The Ritedose Corporation |
| Product type | Drugs |
| Products | 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… |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | CGMP deviation: product released prior to supplier approval. |
| Initiation date | Jul 21, 2023 |
| Report date | Aug 9, 2023 |
| City | Columbia |
| State | SC |
| Country | United States |
| FEI number | 3001237796 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: