Cromolyn Sodium Oral Solution 100 mg/ 96 Plastic Ampules per carton recalled over manufacturing violations

Recall date

July 21, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

The Ritedose Corporation recalls Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules per carton, Rx Only, For Oral Use Only - Not…

Recall number

D-0946-2023

FDA classification

Class II

Brand / firm

The Ritedose Corporation

Sold / distributed

Nationwide in the US

Why it was recalled

CGMP deviation: product released prior to supplier approval.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.