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.
Reported: June 17, 2020 Initiated: April 20, 2020 #D-1297-2020
Product Description
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.
Reason for Recall
Presence of Particulate Matter - found in reserve sample vials at the firm.
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 3,497,575 vials
- Distribution
- USA Nationwide and Puerto Rico
- Location
- Lake Zurich, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Fresenius Kabi USA, LLC. Units affected: 3,497,575 vials.
Why was this product recalled? ▼
Presence of Particulate Matter - found in reserve sample vials at the firm.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 17, 2020. Severity: Moderate. Recall number: D-1297-2020.
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