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
Recalled August 9, 2023 · FDA recall D-0946-2023 · The Ritedose
Hazard
CGMP deviation: product released prior to supplier approval. · FDA Class II
Units
44 cartons
Sold at
Nationwide in the US
Description
CGMP deviation: product released prior to supplier approval.
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.
Manufacturer(s)
The Ritedose Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →