Home / Recalls / The Ritedose Corporation / D-0946-2023

D-0946-2023 Class II

Recalled by The Ritedose Corporation — Columbia, SC

Recall Details

Product Type: Drugs
Report Date: August 9, 2023
Initiation Date: July 21, 2023
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 44 cartons

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.

Reason for Recall

CGMP deviation: product released prior to supplier approval.

Distribution Pattern

Nationwide in the US

Code Information

Lot: 23CE2, Exp. 03/31/2026