# FDA recall D-0946-2023

> **The Ritedose Corporation** · Class II · drug recall initiated 2023-07-21.

## 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.

## Reason for recall

CGMP deviation: product released prior to supplier approval.

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-0946-2023
- **Recalling firm:** The Ritedose Corporation
- **Classification:** Class II
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2023-07-21
- **Report date:** 2023-08-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Columbia, SC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0946-2023

## Citation

> AI Analytics. FDA recall D-0946-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0946-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*