FDAFDA · Food and drugs·Recall number D-1274-2019
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
Published May 15, 2019 · Recall initiated: April 30, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- KETOROLAC TROMETHAMINE
- Manufacturer
- Sagent Pharmaceuticals Inc
- Distributor
- Nationwide USA and Puerto Rico
- Lot
- Lot #: M813513, Exp. Feb 2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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