Fresenius Kabi USA has recalled a single lot of pain and inflammation medication Ketorolac Tromethamine in the form of injection for the potential presence of particulate matter, the U.S. Food and Drug Administration or FDA said in a statement.
The particulate matter was found in reserve sample vials. The recall involves one lot of Ketorolac Tromethamine Injection USP of 30 mg/mL, 1 mL fill in a 2 mL amber vial with expiration date of February 2022.
The recalled product was distributed across the United States to wholesalers, distributors, hospitals, and pharmacies between March 28, 2019 and September 3, 2019.
However, there have been no adverse reports received involving the recalled lot, which was produced and sold in 2019.
The company warned that the administration of products containing particulate matter could obstruct blood vessels. This could result in local irritation of blood vessels, swelling at injection site, tissue inflammation and infection, blood clots traveling to the lung, scarring of the lung tissues, and allergic reactions that could lead to life-threatening consequences.
Ketorolac Tromethamine Injection is a nonsteroidal anti-inflammatory drug (NSAID) that is indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level.
Fresenius Kabi urged customers not to use the product, and return it to Fresenius Kabi.
In November 2020, Fresenius Kabi USA had recalled a single lot of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg /mL), 50 mL fill in a 50 mL vial due to a trace amount of lidocaine present in the lot.
Earlier in April, Fresenius Kabi USA had recalled 13 lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial and 60 mg/2 mL (30 mg/mL), 2 mL fill in a 2 mL amber vial due to the presence of particulate matter composed of the following elements: carbon, silicon, oxygen and polyamides.
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