Drug recall D-1124-2017

Class II Terminated reported Sep 6, 2017

Product

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

Reason for recall

Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.

Lots and codes

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.

Recall details

Recalling firm
Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, CA
Quantity
637,810 vials
Distribution
Distributed throughout the United States
Type
Voluntary: Firm initiated
Recall initiated
August 15, 2017
Terminated
January 14, 2019