D-1124-2017 Class II Terminated
FDA drug recall D-1124-2017 was initiated by Amphastar Pharmaceuticals, Inc. on Aug 15, 2017 and is designated Class II. Reason for recall: Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples. The recall status is terminated (terminated Jan 14, 2019). Affected quantity: 637,810 vials.
Recall details
- Product Type
- Drugs
- Report Date
- Sep 6, 2017
- Initiation Date
- Aug 15, 2017
- Termination Date
- Jan 14, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 637,810 vials
Product 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
Reason for recall
Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
Distribution pattern
Distributed throughout the United States
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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1124-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026