FDA-Drug2022-07-27Class II
Ketamine HCl Injection, USP 30 mg/3 mL (10 mg/mL*) syringes, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-33
Nephron Sterile Compounding Center LLC
Hazard
Lack of Assurance of Sterility
Sold states
Nationwide in the USA
Affected count
30,745 syringes
Manufactured in
4500 12th Street Ext, N/A, West Columbia, SC, United States
Products
Ketamine HCl Injection, USP 30 mg/3 mL (10 mg/mL*) syringes, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-33
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1260-2022Don't want to check this manually?
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