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
Reported: January 6, 2021 Initiated: December 17, 2020 #D-0184-2021
Product Description
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.
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 490,633 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 Vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-162-02. Recalled by Fresenius Kabi USA, LLC. Units affected: 490,633 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 January 6, 2021. Severity: Moderate. Recall number: D-0184-2021.
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