Hikma’s U.S. operation has stopped production of an injected pain drug as it figures out how to fix an issue that has resulted in black, oily and gelatinous particles in some vials of the drug. The drugmaker made the disclosure as it extended its recall to the retailer and medical facilities.
The voluntary recall of eight lots of ketorolac tromethamine injection was initially made in December to the consumer level after Hikma Pharmaceuticals USA got reports of the visible black particles in some vials of the USP 30mg/mL, 1mL fill/2mL dose.
While it has not received any reports of adverse reports, Hikma says there is the risk particles could end up in the lungs of patients and result in “multiple pulmonary microemboli … and cause acute respiratory distress.” The drug is often used to treat pain and inflammation after surgery.
Hikma says the lots were manufactured between March 22, 2018, and Feb. 21, 2019. After investigating the cause of the problem, it says it “decided to suspend manufacturing of this product until an appropriate solution can be implemented to prevent recurrence.”
In April 2019, one lot of the same drug manufactured by Zydus was voluntarily recalled by distributor Sagent Pharmaceuticals to the user level after microbial growth was detected during a routine simulation of the manufacturing process.
In 2015, there was a shortage of the drug in the U.S. after Hospira recalled more than 60 lots of the pain reliever because of the potential for crystals in the 18 million vials that had been shipped in the U.S. and Singapore. Both Hikma and Sagent currently show the drug unavailable on the FDA drug shortages list, although some other producers show it in stock.