FDA Recall Ketorolac Tromethamine

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The last Recall Enforcement Report for Ketorolac Tromethamine with NDC 25021-700 was initiated on 04-30-2019 as a Class II recall due to 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. The latest recall number for this product is D-1274-2019 and the recall is currently terminated as of 09-28-2020 .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-1274-201904-30-201905-15-2019Class II75,825 vialsKetorolac 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: 25021-701-02Terminated
D-0027-201510-03-201410-22-2014Class II69,050 vialsKetorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b) 2 mL vial (NDC 25021-701-02), Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195Terminated

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.