Status
Terminated
Drug Enforcement D-0362-2023
Lack of Assurance of Sterility
Classification
Class II
Report Date
March 8, 2023
Termination Date
September 24, 2024
Product Information
- Product description
- Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 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 69374-321-25.
- Product quantity
- 10,980 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-0362-2023
- Event ID
- 91749
- Recall initiation date
- February 22, 2023
- Center classification date
- February 27, 2023
- Code info
- Lots: PS2008A, Exp. 03/07/2023
- More code info
- —