Drug recall
Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25…
FDA recall event 84534 · Class I, Class II · Hikma Pharmaceuticals USA Inc.
Key facts
| Event ID | 84534 |
|---|---|
| Recall numbers | D-0658-2020, D-0864-2020 |
| Recalling firm | Hikma Pharmaceuticals USA Inc. |
| Product type | Drugs |
| Products | 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…, 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… |
| Classification | Class I, Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS) |
| Initiation date | Dec 17, 2019 |
| Report date | Jan 22, 2020 |
| Termination date | Jun 9, 2021 |
| City | Cherry Hill |
| State | NJ |
| Country | United States |
| FEI number | 2220525 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: