Cromolyn Sodium Oral Solution (concentrate) Solution, Concentrate
FDA Recall NDC 76204-025
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Cromolyn Sodium Oral Solution (concentrate) (NDC 76204-025). A significant event, classified as Class II, was initiated on Jul 21, 2023 by Ritedose Pharmaceuticals, Llc. The reported reason for this action was: "CGMP deviation: product released prior to supplier approval."
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Completed
CGMP deviation: product released prior to supplier approval.
Jul 21, 2023
Aug 09, 2023
44 cartons
Recall Profile & Regulatory Data
Event ID
92754
Classification
Class II
Enforcement Status
Completed
Recalling Firm
The Ritedose Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
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.
Batch or Lot Expiration Information
Lot# Lot: 23CE2, Exp. 03/31/2026
Affected Packages Involved in this Recall
76204-025-08Product
76204-025-96Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
