Status
Terminated
Drug Enforcement D-0361-2023
Lack of Assurance of Sterility
Classification
Class II
Report Date
March 8, 2023
Termination Date
September 24, 2024
Product Information
- Product description
- Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-301-10.
- Product quantity
- 24,870 vials
- 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-0361-2023
- Event ID
- 91749
- Recall initiation date
- February 22, 2023
- Center classification date
- February 27, 2023
- Code info
- Lots: PE2029, Exp. 06/17/2023
- More code info
- —