WASHINGTON, D.C. — International drug manufacturer Fresenius Kabi, in conjunction with the U.S. Food and Drug Administration (FDA), declared a voluntary recall of Ketorolac Tromethamine Injection USP because of contaminates found in reserve samples. Consequently, Fresenius Kabi recalled thirteen lots of the drug. Fresenius Kabi recalled Ketorolac Tromethamine Injection USP, 30 mg/mL, and 60 mg/2 mL doses. The FDA said in a safety alert recently published that the particulate matter was made up of several components, including oxygen, silicon, carbon, and polyamides. The suspect particulate matter appeared in eight sample vials tested from the company’s reserve.
The recall was urgent due to the possible harm that extraneous agents could cause at the injection site. Injecting foreign matter into the bloodstream could irritate blood vessels near the site of the injection. Also, the particulates could obstruct vascular structures. The FDA warned that the particulates could form a mass of tissue that could become inflamed and infected. Additionally, the FDA said blood clots traveling to the lung, particulates scarring the lung tissue, and allergic reactions initiated by the contaminated injection, could have life-threatening consequences. Fresenius Kabi produced the thirteen contaminated lots from May 5, 2018, and December 16, 2019.
The two recalled injections are NSAIDs or nonsteroidal anti-inflammatory medications. The FDA approved the injection for relief from moderate to severe pain typically treated with opioid painkillers. The course of treatment with the medication between the oral solution and injection in five (5) days.
Ketorolac Tromethamine may be sold to consumers with a valid prescription. Accordingly, Fresenius Kabi asked its customers, wholesalers, distributors, and pharmacies to quarantine all recalled lots from non-contaminated lots. The company is accepting the returns of the recalled medication.
Fresenius Kabi asked all patients to consult their physician about alternative medications. Additionally, the company counseled patients to speak with their doctor about possible complications caused by this recall.
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