FDA-Drug2019-05-15Class II
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, NDC: 25021-701-02
Sagent Pharmaceuticals Inc
Hazard
Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.
Sold states
Nationwide USA and Puerto Rico
Affected count
75,825 vials
Manufactured in
1901 N Roselle Rd Ste 700, N/A, Schaumburg, IL, United States
Products
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, NDC: 25021-701-02
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1274-2019Don't want to check this manually?
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