www.fdanews.com/articles/200870-contaminated-lot-of-anti-inflammatory-recalled-by-fresnius-kabi
Contaminated Lot of Anti-Inflammatory Recalled by Fresnius Kabi
January 14, 2021
Fresenius Kabi USA has recalled a single lot of ketorolac tromethamine injection USP 30 mg/mL for possible contamination with particulate matter.
The recalled lot was distributed nationwide in the U.S. to wholesalers, distributors, hospitals and pharmacies between March 28, 2019, and Sept. 3, 2019.
The FDA noted that the contamination could cause a range of adverse events, such as obstructed and irritated blood vessels or life-threatening allergic reactions but said that no adverse events have been reported.