Drug 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.
D-0946-2023
Product summary
- Event
- Event 92754
- Status
- Completed
- Classification
- Class II
- Quantity
- 44 cartons
- Official record key
drug-enforcement:D-0946-2023
Official wording
Reason: CGMP deviation: product released prior to supplier approval.
Code information: Lot: 23CE2, Exp. 03/31/2026
Distribution pattern: Nationwide in the US
Derived failure modes
-
Manufacturing or process control
CGMP deviation