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# Sagent Recalls Ketorolac Tromethamine Due to Sterility
- URL: https://www.fdaweb.com/sagent-recalls-ketorolac-tromethamine-due-to-sterility/
- Published: 2019-05-02T12:00:00.000Z
- Updated: 2026-09-15T01:24:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144011

Sagent Pharmaceuticals has recalled one lot of ketorolac tromethamine injection due to lack of sterility assurance. A [recall notice](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sagent-pharmaceuticals-issues-voluntary-nationwide-recall-ketorolac-tromethamine-injection-usp?utm%5Fcampaign=FDA%20MedWatch%20Ketorolac%20Tromethamine%20Injection&utm%5Fmedium=email&utm%5Fsource=Eloqua) says that microbial growth was detected during a routine simulation of the manufacturing process. The product was manufactured by Zydus (Cadila Healthcare) and distributed by Sagent.