Medications & Supplements/Prescription Drugs

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

Agency Publication Date: December 31, 2020

Summary

Approximately 490,633 vials of Ketorolac Tromethamine Injection (60 mg per 2 mL) have been recalled by Fresenius Kabi USA because particulate matter was discovered in reserve samples of the medication. This prescription nonsteroidal anti-inflammatory drug (NSAID) is used for short-term pain management and was distributed nationwide. Consumers should immediately identify if they have any vials from the affected batch and consult with their healthcare provider.

Risk

The presence of particulate matter in an injectable medication can cause serious health issues, including inflammation, allergic reactions, and the blockage of blood vessels (embolism), which can lead to organ damage or life-threatening complications.

What You Should Do

Check your medication for Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL) in 2 mL single-dose vials under the Fresenius Kabi brand name (NDC 63323-162-02).
Look specifically for Batch # 6121125 with an expiration date of 02/2021 to determine if your product is affected.
If you have the affected product, do not use it; contact your healthcare provider or pharmacist immediately for guidance on alternatives and safety.
Return any unused product from the affected batch to the pharmacy where it was purchased for a refund and contact Fresenius Kabi for further instructions.
Report any adverse reactions or quality problems to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL)

Model:

NDC 63323-162-02

Recall #: D-0184-2021

Lot Numbers:

Batch # 6121125 (Exp 02/2021)

Date Ranges: Expiration Date: 02/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87005

Status: Resolved

Manufacturer: Fresenius Kabi USA, LLC

Sold By: Hospitals; Clinics; Pharmacies

Manufactured In: United States

Units Affected: 490,633 vials

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication for Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL) in 2 mL single-dose vials under the Fresenius Kabi brand name (NDC 63323-162-02).

Look specifically for Batch # 6121125 with an expiration date of 02/2021 to determine if your product is affected.

If you have the affected product, do not use it; contact your healthcare provider or pharmacist immediately for guidance on alternatives and safety.

Return any unused product from the affected batch to the pharmacy where it was purchased for a refund and contact Fresenius Kabi for further instructions.

Report any adverse reactions or quality problems to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.