Prescription oral drug solution recalled due to manufacturing quality deviation
The Ritedose Corporation is recalling Cromolyn Sodium Oral Solution (Concentrate) due to a manufacturing deviation. Lot 23CE2, distributed nationwide, was released prior to obtaining required supplier approval.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries mentioned in the source. The CGMP deviation relates to a manufacturing approval process without a specific patient hazard identified. It qualifies as a precautionary manufacturing recall, consistent with Score 2 (Moderate).
Plain-English summary
The Ritedose Corporation is recalling 44 cartons of Cromolyn Sodium Oral Solution (Concentrate) due to a manufacturing quality issue. The affected product is Lot 23CE2 with an expiration date of March 31, 2026, and was distributed nationwide in the United States.
The recall was initiated due to a Current Good Manufacturing Practice (CGMP) deviation. Specifically, the product was released prior to obtaining the required supplier approval, indicating the product was not fully approved by the supplier before distribution.
The manufacturer is The Ritedose Corporation, located in Columbia, South Carolina, and the product is manufactured for Ritedose Pharmaceuticals LLC. The product is supplied in plastic ampules and is intended for oral use only in concentrated form; it must be diluted before administration. The FDA recall number is D-0946-2023.
The recalled product
- Product
- CROMOLYN SODIUM ORAL SOLUTION (CONCENTRATE) (CROMOLYN SODIUM ORAL SOLUTION (CONCENTRATE))
- Brand
- CROMOLYN SODIUM ORAL SOLUTION (CONCENTRATE)
- Manufacturer
- The Ritedose Corporation
- Category
- Drug — Oral Solution
- Hazard
- manufacturing-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 23CE2
- Exp. 03/31/2026
Distribution
Distributed nationwide across the United States.
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