Cromolyn Sodium Oral Solution 100 mg/5 mL 96 Plastic Ampules per carton Recall: CGMP Deviations
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…
What is the FDA recall status?
The FDA record lists the status as Completed. This does not establish that a retained product is safe to consume or use. FDA enforcement data is not a live recall-lifecycle tracker. Check the agency notice or firm for current guidance.
Why was Cromolyn Sodium Oral Solution 100 mg/5 mL 96 recalled?
CGMP deviation: product released prior to supplier approval.
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full 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.
Which lot codes, UPCs or models are affected?
Lot: 23CE2, Exp. 03/31/2026
- Agency record number
- D-0946-2023
- 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…
- Recalling firm
- The Ritedose Corporation
- Quantity
- 44 cartons
- Distribution
- Nationwide in the US
- Recall started
- July 21, 2023
- Report date
- August 9, 2023
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (drug)