Ketorolac Tromethamine Injection — Class II drug recall D-0658-2020
Terminated recall by Hikma Pharmaceuticals USA Inc., reported 2020-01-22, distributed nationwide. Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
| Recall number | D-0658-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hikma Pharmaceuticals USA Inc., Cherry Hill, NJ, United States |
| Recall initiated | 2019-12-17 |
| Classified | 2020-03-02 |
| Reported by FDA | 2020-01-22 |
| Terminated | 2021-06-09 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 00641-6041, 00641-6041-01, 00641-6041-25, 00641-6042, 00641-6042-01, 00641-6042-25, 00641-6043, 00641-6043-01, 00641-6043-25 |
| Expiration dates | 2020-03-20, 2020-05-20, 2020-07-20, 2020-11-20 |
Product
Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose Vials (NDC 0641-6043-01), 25 vials/shelf-pack (NDC 0641-6043-25), For IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA.
Reason for recall
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
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-0658-2020. 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.