Fresenius Kabi USA, LLC: Ketorolac Tromethamine Injection Recalled for Presence of Particulate Matter

What You Should Do

1. Check your supply for Ketorolac Tromethamine Injection 30 mg per mL (1 mL vials) with NDC 63323-162-00 and look for the following lot numbers and expiration dates: 6118737 (Exp 04/2020), 6118902 (Exp 04/2020), 6119052 (Exp 05/2020), 6119752 (Exp 08/2020), 6122349 (Exp 07/2021), and 6122538 (Exp 09/2021).
2. Check your supply for Ketorolac Tromethamine Injection 60 mg per 2 mL (2 mL vials) with NDC 63323-162-03 and look for the following lot numbers and expiration dates: 6119229 (Exp 06/2020), 6119273 (Exp 06/2020), 6119843 (Exp 09/2020), 6121115 (Exp 02/2021), 6121451 (Exp 03/2021), 6121452 (Exp 03/2021), and 6121496 (Exp 03/2021).
3. Immediately stop using any vials matching these identified lot numbers and set them aside to ensure they are not administered to patients.
4. Contact your healthcare provider or pharmacist immediately if you have used this product and are experiencing any unusual symptoms or health concerns.
5. Return any unused product to the pharmacy or place of purchase for a refund and contact Fresenius Kabi USA for further instructions regarding the return process.
6. For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Your Remedy Options

Affected Products