Drug 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.
D-0245-2021
Product summary
- Event
- Event 87082
- Status
- Terminated
- Classification
- Class I
- Quantity
- 945,425 vials
- Official record key
drug-enforcement:D-0245-2021
Official wording
Reason: Presence of Particulate Matter - found in reserve sample vials at the firm.
Code information: Lot # 6121083, Exp 2/2021
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter