Ketorolac Trom 30 mg/mL Injection — Class II drug recall D-1176-2017
Terminated recall by RemedyRepack Inc., reported 2017-10-04, distributed in LA. Crystallization: Product is being recalled due to the manufacturer's recall due to the presence of visible par
| Recall number | D-1176-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RemedyRepack Inc., Indiana, PA, United States |
| Recall initiated | 2017-08-22 |
| Classified | 2017-09-22 |
| Reported by FDA | 2017-10-04 |
| Terminated | 2018-01-03 |
| Distributed | LA |
| Quantity | 40 vials |
| Reason classes | specification failure |
| NDC | 00548-9021-00, 61786-0741-01, 61786-0741-08 |
| Model numbers | 33631, 33632 |
| Expiration dates | 2017-12 |
Product
Ketorolac Trom 30 mg/mL Injection, packaged in a) 1 mL vials, NDC 61786-0741-01 (Orig: 00548-9021-00), Ref: 33631 and b) 10 x 1 mL vials per tray, NDC 61786-0741-08 (Orig: 00548-9021-00), Ref: 33632, Rx only, Packaged by: RemedyRepack Inc, Indiana, PA 15704; Mfg by: Amphastar, Rancho Cucamonga, CA 91730.
Reason for recall
Crystallization: Product is being recalled due to the manufacturer's recall due to the presence of visible particulate in vials that has been identified as crystalline ketorolac calcium salt.
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-1176-2017. 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.