Cromolyn Sodium Oral Solution 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…
Why was Cromolyn Sodium Oral Solution recalled?
CGMP deviation: product released prior to supplier approval.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: 23CE2, Exp. 03/31/2026
- 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 date
- August 9, 2023
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (drug)