Drug 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
D-0184-2021
Product summary
- Event
- Event 87005
- Status
- Terminated
- Classification
- Class II
- Quantity
- 490,633 vials
- Official record key
drug-enforcement:D-0184-2021
Official wording
Reason: Presence of Particulate Matter - found in reserve sample vials at the firm.
Code information: Batch # 6121125, Exp 02/2021
Distribution pattern: USA Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter