Recall D-0359-2023
Description: Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile 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 69374-302-10.
Recall D-0359-2023 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0359-2023 |
Event ID | 91749 |
Distribution | Nationwide in the USA |
Quantity | 546,450 vials |
Recall Reason | Lack of Assurance of Sterility |
Drug Classification | Class II |
Drug Code Info | 20230308 |
Recall Initiation Date | 20230222 |
Report Date | 20230308 |
Classification Date | 20230227 |
Address | 4500 12th Street Ext West Columbia, SC 29172-3025 United States |
Recalling Firm | Nephron Sterile Compounding Center LLC |
Initial Notification | Letter |
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