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

FDA recall notice · announced January 6, 2021 · Fresenius Kabi

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

Presence of Particulate Matter - found in reserve sample vials at the firm.

Notes

Distribution: USA Nationwide and Puerto Rico
Lot/code information: Batch # 6121125, Exp 02/2021
Quantity: 490,633 vials
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.