In an announcement, Hikma Pharmaceutical noted that the small visible particulate discovered in the nonsteroidal anti-inflammatory drug (NSAID) was ‘gelatinous’ or ‘oily’ in nature and appeared black in some of the recalled lots.
Today’s voluntary recall announcement is the second one that Hikma has initiated, after previously initiating such action on December 23, 2019.
The product, ketorolac tromethamine injection USP 30mg/mL, 1mL fill/2mL vials, was manufactured between March 22, 2018, and February 21, 2019.
Ketorolac tromethamine injection is an NSAID that is used for the short-term management of moderately severe acute pain that requires analgesia at the opioid level.
The manufacturer stated that it is investigating the cause of the problem and had suspended manufacturing of this particular product until “an appropriate solution can be implemented to prevent recurrence.”
Having previously recalled the product from the direct customer level, this has now been extended to the medical facility and retail levels.
The company explained that should affected product be delivered to patients, it could lead to the deposition of the particulates in the lungs of patients, potentially resulting in respiratory problems.
In total, eight lots of the product will be recalled.
Hikma stated that, to date, there have been no reports of adverse events.