FDAJuly 21, 2023drug
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
CGMP deviation: product released prior to supplier approval.
What to do
FDA enforcement status: Completed
Brands named
ritedose
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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