Drug product
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vials (NDC 63323-162-03), 25 x 2 mL Single Dose Vials per tray (NDC 63323-162-02); For IM use only, Not for IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
D-1297-2020
Product summary
- Event
- Event 85504
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,497,575 vials
- Official record key
drug-enforcement:D-1297-2020
Official wording
Reason: Presence of Particulate Matter - found in reserve sample vials at the firm.
Code information: Lot #: 6119229, 6119273, Exp 06/2020; 6119843, Exp 09/2020; 6121115, Exp 02/2021; 6121451, 6121452, 6121496, Exp 03/2021
Distribution pattern: USA Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter