FDA-Drug2023-03-08Class II
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.
Nephron Sterile Compounding Center LLC
Hazard
Lack of Assurance of Sterility
Sold states
Nationwide in the USA
Affected count
546,450 vials
Manufactured in
4500 12th Street Ext, N/A, West Columbia, SC, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0359-2023Don't want to check this manually?
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