Class II
Completed
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.
This recall has been completed (originally issued August 9, 2023).
- Company
- The Ritedose Corporation
- Recall Initiated
- July 21, 2023
- Posted
- August 9, 2023
- Recall Number
- D-0946-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 44 cartons
- Firm Location
- Columbia, SC, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP deviation: product released prior to supplier approval.
Distribution
Nationwide in the US
Lot / Code Info
Lot: 23CE2, Exp. 03/31/2026
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