CLASS II Drug recall · Reported 9 Aug 2023 · FDA Enforcement Report
Cromolyn Sodium Oral Solution (Concentrate) 100 mg recalled
The Ritedose is recalling Cromolyn Sodium Oral Solution (Concentrate) 100 mg/ 96, distributed nationwide in the US. The recall was initiated on 21 Jul 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0946-2023
- FDA event ID
- 92754
- Recalling firm
- The Ritedose, Columbia, SC
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 21 Jul 2023
- FDA classified
- 31 Jul 2023
- Reported
- 9 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Foreign Material
- Drug class
- Injectable & IV Drugs
Timeline
| 21 Jul 2023 | Recall initiated by company | |
| 31 Jul 2023 | Classified by FDA | +10 days |
| 9 Aug 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP deviation: product released prior to supplier approval.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the US
Questions about this recall
Is Cromolyn Sodium Oral Solution (Concentrate) 100 mg/ 96 recalled?
Yes. The Ritedose recalled Cromolyn Sodium Oral Solution (Concentrate) 100 mg/ 96 on 21 Jul 2023. The recall is Class II and its status is Completed. Recall number D-0946-2023.
Why was it recalled?
CGMP deviation: product released prior to supplier approval.
Which lots are affected?
Lot: 23CE2, Exp. 03/31/2026
Where was it sold?
Nationwide in the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from The Ritedose
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | 4% Sodium Chloride Injection, 120 mEq recalled by The Ritedose | The Ritedose | Other | Nationwide |