FDA Recall D-0245-2021
Fresenius Kabi USA, LLC · Lake Zurich, IL
Class I — life-threatening Terminated 898 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
Reason for recall
Presence of Particulate Matter - found in reserve sample vials at the firm.
Recall record
- Recall number
D-0245-2021- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide USA and Puerto Rico
- Recall initiated
- 2020-12-23
- Classified by FDA Center
- 2021-01-27
- FDA published
- 2021-02-03
- Terminated
- 2023-06-09
- Recalling firm
- Fresenius Kabi USA, LLC
- Firm location
- Lake Zurich, IL
Drug identification
- Brand name(s)
- KETOROLAC TROMETHAMINE
- Generic name(s)
- KETOROLAC TROMETHAMINE
- Manufacturer(s)
- Fresenius Kabi USA, LLC
- NDC(s)
63323-161, 63323-162- Route(s)
- INTRAMUSCULAR, INTRAVENOUS