Product: 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
Reason for recall: 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.
Recall initiated: 20190430
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated