Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Recalled by The Ritedose Corporation Due to CGMP deviation: product released prior to supplier approval.

Date: July 21, 2023
Company: The Ritedose Corporation
Status: Completed
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact The Ritedose Corporation directly.

Affected Products

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.

Quantity: 44 cartons

Why Was This Recalled?

CGMP deviation: product released prior to supplier approval.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About The Ritedose Corporation

The Ritedose Corporation has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report