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FDARecalled Aug 9, 2023 · #D-0946-2023

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 C...

Hazard

Class II — temporary health risk

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Description

CGMP deviation: product released prior to supplier approval. Classification: Class II Distribution: Nationwide in the US

Product details

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, Must be Diluted, Manufactured by: The Ritedose Corporation Columbia, SC 29203 for Ritedose Pharmaceuticals, LLC Columbia, SC 29203, NDC 76204-025-96.
Type
Drugs
Manufacturer
The Ritedose Corporation
Model numbers
23CE2
UPCs