Medications & Supplements/Prescription Drugs

Sagent Pharmaceuticals Inc: Ketorolac Tromethamine Injection Recalled for Lack of Sterility Assurance

Agency Publication Date: May 9, 2019

Summary

Sagent Pharmaceuticals has recalled 75,825 vials of Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL). This prescription medication is being recalled because microbial growth was detected during a routine simulation of the manufacturing process, which means the product may not be sterile. The recall affects Lot M813513 with an expiration date of February 2020, which was distributed nationwide across the USA and Puerto Rico.

Risk

The lack of sterility assurance means that microorganisms may have been introduced into the injectable product. Using a non-sterile injectable medication can lead to serious systemic infections or localized site-of-injection infections, posing a significant health risk to patients.

What You Should Do

Immediately check your medical supplies for Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL) in 2 mL vials with NDC 25021-701-02.
Verify if your product belongs to Lot #: M813513 with an expiration date of February 2020.
If you identify an affected vial, do not use the medication. Contact your healthcare provider or pharmacist immediately for guidance on alternative treatments and to report the affected product.
Return any unused product from the affected lot to your pharmacy or the place of purchase for a refund.
Contact Sagent Pharmaceuticals for further instructions regarding the return or disposal of the product.
For additional questions or to report a problem, 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), 2 mL Vials

Model:

NDC: 25021-701-02

Recall #: D-1274-2019

Lot Numbers:

M813513 (Exp. Feb 2020)

Date Ranges: Expiration February 2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82741

Status: Resolved

Manufacturer: Sagent Pharmaceuticals Inc

Manufactured In: United States

Units Affected: 75,825 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

Immediately check your medical supplies for Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL) in 2 mL vials with NDC 25021-701-02.

Verify if your product belongs to Lot #: M813513 with an expiration date of February 2020.

If you identify an affected vial, do not use the medication. Contact your healthcare provider or pharmacist immediately for guidance on alternative treatments and to report the affected product.

Return any unused product from the affected lot to your pharmacy or the place of purchase for a refund.

Contact Sagent Pharmaceuticals for further instructions regarding the return or disposal of the product.

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