Ketorolac Tromethamine Injection — Class II drug recall D-1124-2017
Terminated recall by Amphastar Pharmaceuticals, Inc., reported 2017-09-06, distributed nationwide. Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained sample
| Recall number | D-1124-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, CA, United States |
| Recall initiated | 2017-08-15 |
| Classified | 2017-08-29 |
| Reported by FDA | 2017-09-06 |
| Terminated | 2019-01-14 |
| Distributed | Nationwide (US) |
| Quantity | 637,810 vials |
| Reason classes | specification failure |
| NDC | 00548-9021-00 |
| Lot numbers | 1/19, 10/18, 11/18, 12/17, 12/18, 2/19, 3/19, 6/18, 7/18, 8/18, 9/18, XI002A6, XI003A6, XI004G6, XI005G6, XI007H6, XI00816, XI00916, XI01016, XI01116, XI012J6, XI013J6, XI015K6, XI016L6, XI019A7, XI020B7, XI021B7, XI022C7, XI023C7, XI025D7, XL018A7 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1124-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.