Reported Sep 6, 2017 · Terminated
Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx only, Amphastar Pharmaceuticals,…
Amphastar Pharmaceuticals, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Amphastar Pharmaceuticals, Inc. · 11570 6th St · Rancho Cucamonga, CA · 91730-6025
Is this the product you have?
- 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
- Lot codes and dates
11 of 11 products
Products covered by this recall # Product as published 1 Lot # XI002A6, XI003A6, Exp 12/17 2 XI004G6, XI005G6, Exp 6/18 3 XI007H6, Exp 7/18 4 XI00816, XI00916, XI01016, XI01116, Exp 8/18 5 XI012J6, XI013J6, Exp 9/18 6 XI015K6, Exp 10/18 7 XI016L6, Exp 11/18 8 XL018A7, XI019A7, Exp 12/18 9 XI020B7, XI021B7, Exp 1/19 10 XI022C7, XI023C7, Exp 2/19 11 XI025D7, Exp 3/19. - Amount recalled
- 637,810 vials
Why it was recalled
Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
This product could cause temporary or reversible health problems — stop using it.
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