FDA-Drug2023-08-09Class II
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.
The Ritedose Corporation
Hazard
CGMP deviation: product released prior to supplier approval.
Sold states
Nationwide in the US
Affected count
44 cartons
Manufactured in
1 Technology Cir, N/A, Columbia, SC, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0946-2023Don't want to check this manually?
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