Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials Supply Disruption — Sagent Pharmaceuticals Inc (M
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials Supply Disruption — Sagent Pharmaceuticals Inc (M is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials; Manufacturer: Sagen
| Drug name | Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials |
|---|---|
| Manufacturer | Sagent Pharmaceuticals Inc |
| Recall/Disruption reason | Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which r |
| Risk classification | Moderate Risk — Temporary Health Consequence |
| Status | Terminated |
| Record type | Enforcement/Recall |
| Recall number | D-1274-2019 |
| Initiation date | 20190430 |
| Quantity affected | 75,825 vials |
| Dosage form | Drugs |
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