FDA-Drug2022-06-08Class II

Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL), 150 mL IV Bag, 10 x 1 IV Bag, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-523-21

Nephron Sterile Compounding Center LLC
Hazard

Lack of Assurance of Sterility

Sold states
Nationwide in the USA
Affected count
3532 bags
Manufactured in
4500 12th Street Ext, N/A, West Columbia, SC, United States
Products
Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL), 150 mL IV Bag, 10 x 1 IV Bag, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-523-21

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0954-2022

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