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 for recall: CGMP deviation: product released prior to supplier approval.
Recall initiated: 20230721
Status: Completed
Classification: Class II
Recall type: Voluntary: Firm initiated