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.
Reported: February 3, 2021 Initiated: December 23, 2020 #D-0245-2021
Product Description
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.
Reason for Recall
Presence of Particulate Matter - found in reserve sample vials at the firm.
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 945,425 vials
- Distribution
- Nationwide USA and Puerto Rico
- Location
- Lake Zurich, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Fresenius Kabi USA, LLC. Units affected: 945,425 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 February 3, 2021. Severity: Critical. Recall number: D-0245-2021.
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