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.
Drug Recall
Official source record
- Recall number
- D-0658-2020
- Event ID
- 84534
- Classification
- Class II
- Status
- Terminated
- Recalling company
- Hikma Pharmaceuticals USA Inc.
- Reason for recall
- Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
- Report date
- January 22, 2020
- Recall initiation date
- December 17, 2019
- Termination date
- June 9, 2021
- Distribution pattern
- Nationwide within the United States
Drug product identifiers
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Brand name
- KETOROLAC TROMETHAMINE
- Generic name
- KETOROLAC TROMETHAMINE
- Substance name
- KETOROLAC TROMETHAMINE
- Product NDCs
- 0641-6041; 0641-6042; 0641-6043
- Package NDCs
- 0641-6041-01; 0641-6041-25; 0641-6042-01; 0641-6042-25; 0641-6043-01; 0641-6043-25
- Routes
- INTRAMUSCULAR; INTRAVENOUS
Where this information comes from
View FDA enforcement record -- the specific openFDA drug enforcement record this summary was built from.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for details.
Retrieved by Public Health Trace:
Frequently asked questions
What does a Class II mean?
A situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote.
Is this recall still active?
According to the FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this medication?
Do not start, stop, or change any medication based on this page. Follow the instructions published by the FDA and the recalling company (see the source links below), and talk to your pharmacist or physician if you have questions about a specific medication.
Where can I find more official information?
The source links below, published by the FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.
Public Health Trace republishes official FDA drug recall information -- it is not affiliated with the FDA, does not verify or supplement what the source has published, and does not provide medical advice. Never start, stop, or change a medication based on this page. Always follow the guidance of your pharmacist or physician, and consult the official source links above for the most current information. Read the full medical disclaimer.
