Recalls / Class II
Class IID-0184-2021
Product
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
- Brand name
- Ketorolac Tromethamine
- Generic name
- Ketorolac Tromethamine
- Active ingredient
- Ketorolac Tromethamine
- Route
- Intramuscular, Intravenous
- NDCs
- 63323-161, 63323-162
- FDA application
- ANDA075784
- Affected lot / code info
- Batch # 6121125, Exp 02/2021
Why it was recalled
Presence of Particulate Matter - found in reserve sample vials at the firm.
Recalling firm
- Firm
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Corporate Dr, N/A, Lake Zurich, Illinois 60047-8930
Distribution
- Quantity
- 490,633 vials
- Distribution pattern
- USA Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2020-12-17
- FDA classified
- 2020-12-31
- Posted by FDA
- 2021-01-06
- Terminated
- 2023-06-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0184-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.