FDA-Drug2022-06-08Class II

Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-955-10

Nephron Sterile Compounding Center LLC
Hazard

Lack of Assurance of Sterility

Sold states
Nationwide in the USA
Affected count
57810 syringes
Manufactured in
4500 12th Street Ext, N/A, West Columbia, SC, United States
Products
Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-955-10

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0965-2022

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