Ketorolac Tromethamine Injection recall: Particulate Matter
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.
Why was Ketorolac Tromethamine Injection recalled?
Presence of Particulate Matter - found in reserve sample vials at the firm.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 6119229, 6119273, Exp 06/2020; 6119843, Exp 09/2020; 6121115, Exp 02/2021; 6121451, 6121452, 6121496, Exp 03/2021
- Product
- 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.
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 3,497,575 vials
- Distribution
- USA Nationwide and Puerto Rico
- Recall date
- June 17, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)