FDA-Drug2022-06-08Class II

Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP, 500 mL Single-Dose Container Bag, 10 x 1 IV Bag, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-543-50

Nephron Sterile Compounding Center LLC
Hazard

Lack of Assurance of Sterility

Sold states
Nationwide in the USA
Affected count
3587 bags
Manufactured in
4500 12th Street Ext, N/A, West Columbia, SC, United States
Products
Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP, 500 mL Single-Dose Container Bag, 10 x 1 IV Bag, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-543-50

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0964-2022

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