Recalls / Class II
Class IID-0946-2023
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.
- Brand name
- Cromolyn Sodium Oral Solution (concentrate)
- Generic name
- Cromolyn Sodium Oral Solution (concentrate)
- Active ingredient
- Cromolyn Sodium
- Route
- Oral
- NDC
- 76204-025
- FDA application
- ANDA209264
- Affected lot / code info
- Lot: 23CE2, Exp. 03/31/2026
Why it was recalled
CGMP deviation: product released prior to supplier approval.
Recalling firm
- Firm
- The Ritedose Corporation
- Manufacturer
- Ritedose Pharmaceuticals, LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 1 Technology Cir, N/A, Columbia, South Carolina 29203-9591
Distribution
- Quantity
- 44 cartons
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2023-07-21
- FDA classified
- 2023-07-31
- Posted by FDA
- 2023-08-09
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0946-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.