Medications & Supplements/Prescription Drugs

RemedyRepack Inc.: Ketorolac Tromethamine Injection Recalled for Particulate Matter

Agency Publication Date: February 13, 2020

Summary

RemedyRepack Inc. is recalling 75 vials of Ketorolac Tromethamine (30 mg/1mL), a prescription nonsteroidal anti-inflammatory drug (NSAID) used for pain management. The medication was relabeled at a facility and is being recalled because the original manufacturer discovered small black particles during a routine visual inspection of retain samples. These particles were found in 1 ml vials distributed in Oklahoma and Louisiana between June 2018 and November 2018.

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, which could lead to a stroke, heart attack, or damage to other organs.

What You Should Do

Check your medication records or vial labels for Ketorolac Tromethamine 30 mg/1mL Injection (NDC 70518-1239-00) repackaged by RemedyRepack Inc.
Verify if your product matches Lot # B0444562-060118 (Exp. 04/2020) or Lot # B0537002-112118 (Exp. 07/2020).
Contact your healthcare provider or pharmacist immediately for guidance if you have this medication in your possession.
Return any unused vials to the pharmacy where you received them for a refund and to ensure they are properly disposed of.
Contact RemedyRepack Inc. at their Indiana, PA facility for further instructions regarding this recall.
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

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a 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 Trom, 30 mg/1mL Inj. for I.V./I.M. Use (1 ml vial)

Model:

NDC 70518-1239-00

Recall #: D-0867-2020

Lot Numbers:

B0444562-060118 (exp. 04/2020)

B0537002-112118 (exp. 07/2020)

Date Ranges: exp. 04/2020, exp. 07/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84900

Status: Resolved

Manufacturer: RemedyRepack Inc.

Manufactured In: United States

Units Affected: 75 1 ml vials

Distributed To: Oklahoma, Louisiana

Agency Last Updated: March 3, 2020

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 records or vial labels for Ketorolac Tromethamine 30 mg/1mL Injection (NDC 70518-1239-00) repackaged by RemedyRepack Inc.

Verify if your product matches Lot # B0444562-060118 (Exp. 04/2020) or Lot # B0537002-112118 (Exp. 07/2020).

Contact your healthcare provider or pharmacist immediately for guidance if you have this medication in your possession.

Return any unused vials to the pharmacy where you received them for a refund and to ensure they are properly disposed of.

Contact RemedyRepack Inc. at their Indiana, PA facility for further instructions regarding this recall.

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