FDA-Drug2023-03-08Class II
Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-997-15.
Nephron Sterile Compounding Center LLC
Hazard
Lack of Assurance of Sterility
Sold states
Nationwide in the USA
Affected count
4,743 bottles
Manufactured in
4500 12th Street Ext, N/A, West Columbia, SC, United States
Products
Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-997-15.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0355-2023Don't want to check this manually?
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