Lupin announced a voluntary recall of certain lots of Ceftriaxone for Injection 250mg, 500mg, 1g, and 2g due to visible grey particulate matter seen in reconstituted vials. The issue was identified upon standard visual inspection before administration to the patient and was not observed prior to reconstitution.
Ceftriaxone is a broad-spectrum cephalosporin antibiotic indicated for the treatment of the following infections when caused by susceptible organisms: lower respiratory tract infections, skin and skin structure infections, bone and joint infections, acute otitis media, urinary tract infections (complicated and uncomplicated), septicemia, pelvic inflammatory disease, intraabdominal infections, meningitis, and uncomplicated gonorrhea. It is also indicated for preoperative administration to reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated and in surgical patients for whom infection at the operative site would present serious risk.
Specifically, the recall includes 5 lots of Ceftriaxone for Injection 250mg, 10 lots of Ceftriaxone for Injection 500mg, 24 lots of Ceftriaxone for Injection 1g, and 3 lots of Ceftriaxone for Injection 2g. The product is packaged in cartons containing 1 or 10 vials. The recalled lots were distributed nationally to wholesalers and drug chains. The full list of recalled lots can be found here.
According to the Company, reconstituting using improper piercing technique and a needle >21 gauge can push rubber flecks into the solution. If the product containing rubber particulate matter is injected, it may cause vein irritation/phlebitis or pulmonary embolic events that could result in permanent impairment or damage to the body. Moreover, the product may cause local muscle inflammation and/or abscesses if administered intramuscularly.
At this time, no reports of adverse events related to this recall have been reported.
For more information call (855) 838-5786 or visit LupinPharmaceuticals.com.