The Ritedose Corporation: Drug Recall

Recall #D-0946-2023 · 07/21/2023

Class II: Risk

Recall Details

Recall Number: D-0946-2023
Classification: Class II
Product Type: Drug
Recalling Firm: The Ritedose Corporation
Status: Completed
Date Initiated: 07/21/2023
Location: Columbia, SC, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 44 cartons

Reason for Recall

CGMP deviation: product released prior to supplier approval.

Product Description

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.

Distribution Pattern

Nationwide in the US

Other Recalls by The Ritedose Corporation

Class III: Low Risk 04/01/2022

Labeling: Incorrect Barcode: Product barcode incorrectly identifies the product as rocuronium bromide injection 100 mg per 10 mL instead of sodium chloride injection 23.4%, 120 mEq per 30 mL.

View all recalls by The Ritedose Corporation →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.