The recall comes after Ceftriaxone for injection products have been found to contain visual grey particulate matter in reconstituted vials.
The five lots recalled contained Ceftriaxone for Injection, 250mg, 10 lots of Ceftriaxone for Injection, 500mg, 24 lots of Ceftriaxone for Injection, 1g, and three lots of Ceftriaxone for Injection, 2g.
Lupin stated that improper piercing and use of a needle greater than 21 gauge while reconstituting the vial can push rubber flecks into the solution.
No grey flecks were seen prior to the constitution of the vials. The issue was identified after standard visual inspection prior to patient administration.
The product containing rubber particulate matter could cause vein irritation or pulmonary embolic events potentially resulting in permanent impairment of bodily function if injected with the contaminant.
As ceftriaxone can be administered intramuscularly, the use of the product with its contaminant can cause local muscle inflammation and abscesses.
Ceftriaxone is a sterile, semi-synthetic, broad-spectrum cephalosporin antibiotic used to reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone sodium, and other antibacterial drugs.