FDA-Drug2022-06-08Class II
Calcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL, 1 g/10 mL (100 mg/mL), 10 mL Pre-Filled Syringe, 5 x 10 Pre-filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-950-10
Nephron Sterile Compounding Center LLC
Hazard
Lack of Assurance of Sterility
Sold states
Nationwide in the USA
Affected count
30180 syringes
Manufactured in
4500 12th Street Ext, N/A, West Columbia, SC, United States
Products
Calcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL, 1 g/10 mL (100 mg/mL), 10 mL Pre-Filled Syringe, 5 x 10 Pre-filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-950-10
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0951-2022Don't want to check this manually?
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