Status
Completed
Drug Enforcement D-0946-2023
CGMP deviation: product released prior to supplier approval.
Classification
Class II
Report Date
August 9, 2023
Termination Date
—
Product Information
- Product description
- 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.
- Product quantity
- 44 cartons
- Reason for recall
- CGMP deviation: product released prior to supplier approval.
- Recall initiation reason
- —
- Initial firm notification
- Distribution pattern
- Nationwide in the US
Location & Firm
- Recalling firm
- The Ritedose Corporation
- Address
-
1 Technology Cir, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0946-2023
- Event ID
- 92754
- Recall initiation date
- July 21, 2023
- Center classification date
- July 31, 2023
- Code info
- Lot: 23CE2, Exp. 03/31/2026
- More code info
- —