Reported Aug 9, 2023 · Completed
Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules per carton, Rx Only, For Oral Use Only - Not…
The Ritedose Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: The Ritedose Corporation · 1 Technology Cir · Columbia, SC · 29203-9591
Is this the product you have?
- 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 ColumbiaSC 29203 for Ritedose PharmaceuticalsLLC ColumbiaSC 29203NDC 76204-025-96
- Lot codes and dates
- Lot
23CE2Exp. 03/31/2026
- Lot
- Amount recalled
- 44 cartons
Where it was sold
- Nationwide
Why it was recalled
CGMP deviation: product released prior to supplier approval.
This product could cause temporary or reversible health problems — stop using it.
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