FDAFDA · Food and drugs·Recall number D-1124-2017
Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx only, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, CA 91730, NDC 0548-9021-00
Published September 6, 2017 · Recall initiated: August 15, 2017
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
Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Amphastar Pharmaceuticals, Inc.
- Distributor
- Distributed throughout the United States
- Lot
- Lot # XI002A6, XI003A6, Exp 12/17; XI004G6, XI005G6, Exp 6/18; XI007H6, Exp 7/18; XI00816, XI00916, XI01016, XI01116, Exp 8/18; XI012J6, XI013J6, Exp 9/18; XI015K6, Exp 10/18; XI016L6, Exp 11/18; XL018A7, XI019A7, Exp 12/18; XI020B7, XI021B7, Exp 1/19; XI022C7, XI023C7, Exp 2/19; XI025D7, Exp 3/19.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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