The FDA has highlighted the voluntary recall of an injectable NSAID pain reliever called Ketorolac Tromethamine from Fresenius Kabi USA. According to the agency, a total of 13 lots of the injectable medication has been recalled over ‘particulate matter’ featuring oxygen, silicon, carbon, and polyamides were found in eight sample vials. Injecting this medication may result in serious, life-threatening complications, the recall notes.
According to the FDA, Ketorolac Tromethamine is a non-steroidal anti-inflammatory drug that is used to treat moderately-severe pain for up to five days. On April 20, Fresenius Kabi announced its voluntary recall of 13 lots of this injectable, specifically the 60mg/2mL and 30mg/mL in 2mL amber vials.
The company notes that the particulate detected in the vials may cause various issues when the drug is injected, including the possibility of a deadly allergic reaction, as well as the formation of blood clots, blood vessel irritation, injection site swelling, the inflammation and infection of a ‘mass of tissue,’ or obstructed blood vessels.
Both distributors and users of the drug are being notified about the recall by letter; the use of these recalled vials should be stopped immediately, according to Fresenius Kabi, which is accepting returns of the product. The company is also answering questions for customers who have questions about the recall. The FDA has a full list of recalled vials, including batch numbers, on its website here.
The FDA says that anyone who is taking this product who experiences any issues related to it should contact their doctors for evaluation. Both the FDA and the pharmaceutical company are accepting adverse event reports from consumers who believe they experienced a reaction from the medication.