Sagent Pharmaceuticals Inc Recall: Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (
Sagent Pharmaceuticals Inc Recall: Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL ( is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Sagent Pharmaceuticals Inc; Product: Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only, Mfd. for Sagent Pha
| Recalling firm | Sagent Pharmaceuticals Inc |
|---|---|
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Nationwide USA and Puerto Rico |
| Recall initiated | 20190430 |
| Recall number | D-1274-2019 |
| Category | drug |
| State | IL |
| Country | United States |
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