Status
Terminated
Drug Enforcement D-0355-2023
Lack of Assurance of Sterility
Classification
Class II
Report Date
March 8, 2023
Termination Date
September 24, 2024
Product Information
- Product description
- Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-997-15.
- Product quantity
- 4,743 bottles
- Reason for recall
- Lack of Assurance of Sterility
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Nephron Sterile Compounding Center LLC
- Address
-
4500 12th Street Ext, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0355-2023
- Event ID
- 91749
- Recall initiation date
- February 22, 2023
- Center classification date
- February 27, 2023
- Code info
- Lots: DS2053, Exp. 2/27/2023
- More code info
- —