Drug 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
D-1124-2017
Product summary
- Event
- Event 77988
- Status
- Terminated
- Classification
- Class II
- Quantity
- 637,810 vials
- Official record key
drug-enforcement:D-1124-2017
Official wording
Reason: Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
Code information: 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.
Distribution pattern: Distributed throughout the United States
Derived failure modes
-
Foreign material or chemical contamination
Particulate matter