Fresenius Kabi Recalls Ketorolac Tromethamine Injection, USP
The company is voluntarily recalling 13 lots of the product because of particulate matter found in reserve sample vials.
Fresenius Kabi announced on April 20, 2020 that it was voluntarily recalling 13 lots of Ketorolac Tromethamine Injection, USP and 30 mg/mL, 1-mL fill in a 2-mL amber vial and Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2-mL fill in a 2-mL amber vial. The recall is being made after particulate matter composed of carbon, silicon, oxygen and polyamide was found in eight reserve sample vials.
According to the company, Ketorolac Tromethamine is a nonsteroidal anti-inflammatory drug used for short-term management of moderately severe acute pain. Use of product that contains particulate matter could obstruct blood vessels and cause local irritation of blood vessels, swelling at the injection site, inflamed and infected tissue, blood clots, and allergic reactions.
The recalled lots were distributed nationwide to wholesalers, distributors, hospitals, and pharmacies between May 5, 2018 and December 16, 2019. More information on the recalled lots can be found on FDA’s website. Adverse events may be reported to FDA through the agency’s MedWatch program.
Source: FDA
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
