CLASS II Drug recall · Reported 22 Jan 2020 · FDA Enforcement Report
Ketorolac Tromethamine Injection, USP 60 mg/ (30 mg/mL) recalled
Hikma Pharmaceuticals USA is recalling Ketorolac Tromethamine Injection, USP 60 mg/ (30 mg/mL), distributed nationwide in the US. The recall was initiated on 17 Dec 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0658-2020
- FDA event ID
- 84534
- Recalling firm
- Hikma Pharmaceuticals USA, Cherry Hill, NJ
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Dec 2019
- FDA classified
- 2 Mar 2020
- Reported
- 22 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Pain Medication
Timeline
| 17 Dec 2019 | Recall initiated by company | |
| 22 Jan 2020 | Published in enforcement report | +36 days |
| 2 Mar 2020 | Classified by FDA | +40 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Product as listed by the FDA
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.
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Which lots are affected?
038368, Exp. Mar 2020; 058314, Exp. May 2020; 078305, 078307, Exp. July 2020; 118362 Exp. Nov 2020
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 84534| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Ketorolac Tromethamine Injection, USP 30 mg/mL recalledKetorolac Tromethamine | Hikma Pharmaceuticals USA | Particulate Matter | Nationwide |
More recalls from Hikma Pharmaceuticals USA
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ramipril Capsules USP, 10 mg recalled by Hikma Pharmaceuticals USARamipril | Hikma Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Alendronate Sodium Oral Solution, 70 mg recalledAlendronate Sodium | Hikma Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Lorazepam Injection, USP, 2 mg/mL, 25 x vials/carton recalledLorazepam | Hikma Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS I | Acetaminophen Injection, 1,000 mg recalled by Hikma Pharmaceuticals USAAcetaminophen | Hikma Pharmaceuticals USA | Packaging Defects | OH, PR |
| Drug | CLASS II | Infumorph (Preservative-free Morphine Sulfate Sterile recalledInfumorph 200 | Hikma Pharmaceuticals USA | Other | Nationwide |
Other Ketorolac Tromethamine recalls
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ketorolac Tromethamine Injection, USP, 60 mg recalled by Aspiro PharmaKetorolac Tromethamine | Aspiro Pharma | Particulate Matter | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution recalled by Akorn | Akorn | Manufacturing (CGMP) Deviations | Nationwide |