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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Ritedose Cromolyn Sodium Oral Solution Recalled for Manufacturing Deviation

Agency Publication Date: July 31, 2023
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Summary

The Ritedose Corporation has recalled 44 cartons of Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL, a prescription medication used to manage certain allergic conditions. This recall was issued due to a manufacturing deviation where the product was released for distribution before the supplier had been officially approved. There have been no reported incidents or injuries related to this recall to date.

Risk

The drug was released without following required quality control procedures regarding supplier approval. This failure to meet manufacturing standards could potentially impact the quality or safety of the medication, although no specific health hazards have been identified.

What You Should Do

  1. This recall affects Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL packaged in cartons containing 96 plastic ampules, sold under NDC 76204-025-96.
  2. Check the medication carton for lot number 23CE2 with an expiration date of 03/31/2026.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact The Ritedose Corporation for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mLby Ritedose Pharmaceuticals, LLC
Variants: 100 mg/5 mL, Concentrate, 96 Plastic Ampules per carton
Lot Numbers:
23CE2 (Exp. 03/31/2026)
NDC:
76204-025-96

Rx Only; Manufactured by The Ritedose Corporation for Ritedose Pharmaceuticals, LLC; Recall #: D-0946-2023

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92754
Status: Resolved
Manufacturer: The Ritedose Corporation
Sold By: Ritedose Pharmaceuticals, LLC
Manufactured In: United States
Units Affected: 44 cartons
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.