Multi event Drug Recall Enforcement Report Class II voluntary initiated by Hikma Pharmaceuticals USA Inc., originally initiated on 12-17-2019 for the 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. The product was recalled due to presence of particulate matter: particles identified as polydimethylsiloxane (pdms). The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0658-2020 | 12-17-2019 | 01-22-2020 | Class II | 25,817 shelf packs/25 vials per pack | 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. | Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS) | Terminated |
| D-0864-2020 | 12-17-2019 | 01-22-2020 | Class I | 101,710 25 vials/shelf-pack | Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25 vials/shelf-pack (NDC 0641-6042-25), For IV or IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA. | Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS) | Terminated |
Recalled Products
