Recalls / Class I
Class ID-0245-2021
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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.
- 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
- Lot # 6121083, Exp 2/2021
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, Lake Zurich, Illinois 60047-8930
Distribution
- Quantity
- 945,425 vials
- Distribution pattern
- Nationwide USA and Puerto Rico
Timeline
- Recall initiated
- 2020-12-23
- FDA classified
- 2021-01-27
- Posted by FDA
- 2021-02-03
- Terminated
- 2023-06-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0245-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.