Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ketorolac Tromethamine Injection Recalled by Sagent Pharmaceuticals Inc Due to Lack of Sterility Assurance: Microbial growth detected during...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sagent Pharmaceuticals Inc directly.
Affected Products
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
Quantity: 75,825 vials
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sagent Pharmaceuticals Inc
Sagent Pharmaceuticals Inc has 16 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report