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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Amphastar Pharmaceuticals, Inc.
- Reason for Recall:
- Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1124-2017