Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-162-02
Drug Recall
Official source record
- Recall number
- D-0184-2021
- Event ID
- 87005
- Classification
- Class II
- Status
- Terminated
- Recalling company
- Fresenius Kabi USA, LLC
- Reason for recall
- Presence of Particulate Matter - found in reserve sample vials at the firm.
- Report date
- January 6, 2021
- Recall initiation date
- December 17, 2020
- Termination date
- June 20, 2023
- Distribution pattern
- USA Nationwide and Puerto Rico
Drug product identifiers
- Manufacturer
- Fresenius Kabi USA, LLC
- Brand name
- KETOROLAC TROMETHAMINE
- Generic name
- KETOROLAC TROMETHAMINE
- Substance name
- KETOROLAC TROMETHAMINE
- Product NDCs
- 63323-161; 63323-162
- Package NDCs
- 63323-161-00; 63323-161-01; 63323-162-00; 63323-162-01; 63323-162-02; 63323-162-03; 63323-162-11; 63323-162-51
- Routes
- INTRAMUSCULAR; INTRAVENOUS
Where this information comes from
View FDA enforcement record -- the specific openFDA drug enforcement record this summary was built from.
This record comes from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
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Frequently asked questions
What does a Class II mean?
FDA classifies this recall as Class II. See how to read an FDA recall record for what each classification level means.
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.
Official guidance and record verification
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How to interpret this historical record
This record is preserved as published by FDA, as of June 20, 2023.
Status as reported: Terminated.
This page does not imply a current danger or a current consumer instruction -- review the official source for the most current information.
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.