FDA-Drug2023-01-18Class II

Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-924-05

Nephron Sterile Compounding Center LLC
Hazard

Lack of Assurance of Sterility

Sold states
Nationwide in the USA.
Affected count
38,830 syringes
Manufactured in
4500 12th Street Ext, West Columbia, SC, United States
Products
Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-924-05

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0099-2023

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