Class I, II Recalls for Pain Injection

Fresenius Kabi USA is recalling 13 lots of ketorolac tromethamine injection, 30 mg/mL, 1-mL fill in a 2-mL amber vial, and ketorolac tromethamine injection, 60 mg/2 mL (30 mg/mL), 2-mL fill in a 2-mL amber vial, because particulate matter was found in eight reserve sample vials. According to the June 17, 2020, US Food and Drug Administration (FDA) Enforcement Report, the recalls have been designated Class I and Class II.  

“Administration of products containing particulate matter could obstruct blood vessels and result in local irritation of blood vessels, swelling at the site of injection, a mass of tissue that could become inflamed and infected, blood clots traveling to the lung, scarring of the lung tissues, and allergic reactions that could lead to life-threatening consequences,” Fresenius Kabi stated in an April 20, 2020, statement announcing the voluntary recalls. 

The FDA designated the recalls Class I and Class II on June 8, 2020. 

The Class I recall, a designation that suggests use of the affected product could cause serious adverse health consequences or death, is for ketorolac tromethamine injection, 30 mg per mL, packaged in 1-mL single-dose vials (NDC 63323-162-00), 25 x 1-mL vials per tray (NDC 63323-162-01), for intramuscular or intravenous use. Recalled vials are from lots 6118737 and 6118902 (Exp. 4/20), 6119052 (Exp. 5/20), 6119752 (Exp. 8/20), 6122349 (Exp. 7/21), and 6122538 (Exp. 9/21). 

The Class II recall, a designation that communicates use of the product may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm, is for ketorolac tromethamine injection, 60 mg per 2 mL (30 mg per mL), packaged in 2-mL single- dose vials (NDC 63323-162-03), 25 x 2-mL vials per tray (NDC 63323-162-02), for intramuscular use only and not for intravenous use. Recalled vials are from lots 6119229 and 6119273 (Exp. 6/20), 6119843 (Exp. 9/20), 6121115 (Exp. 2/21), and 6121451, 6121452, and 6121496 (Exp 3/21). 

All recalled vials were distributed to wholesalers, distributors, hospitals, and pharmacies throughout the United States and in Puerto Rico between May 5, 2018, and December 16, 2019.

Ketorolac tromethamine, a nonsteroidal anti-inflammatory prescription medication, is indicated for the short-term management of moderately severe acute pain that requires analgesia at the opioid level.

—Jolynn Tumolo