FDAFDA · Food and drugs·Recall number D-0946-2023
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.
Published August 9, 2023 · Recall initiated: July 21, 2023
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP deviation: product released prior to supplier approval.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- The Ritedose Corporation
- Distributor
- Nationwide in the US
- Lot
- Lot: 23CE2, Exp. 03/31/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.