
Lupin Pharmaceuticals, Inc. Recalls Ceftriaxone for Injection
The company is recalling 5 lots of Ceftriaxone for Injection, USP, 250mg; 10 lots of Ceftriaxone for Injection, USP, 500mg; 24 lots of Ceftriaxone for Injection, USP, 1g; and 3 lots of Ceftriaxone for Injection, USP 2g because of the presence of particulate matter in reconstituted vials.
FDA
Injection of product containing rubber particulate matter from the stopper could “cause vein irritation/phlebitis or pulmonary embolic events that could result in permanent impairment of body function or damage to body structures, such as the lungs and vascular system. In addition, as ceftriaxone can be administered intramuscularly, the use of the product may result in local muscle inflammation and/or abscesses,” according to the press release. Ceftriaxone for Injection, USP, is used to prevent the development of drug-resistant bacteria and maintain the effectiveness of other antibacterial drugs.
Information on the recalled products and lot numbers can be found on FDA’s
Source:
Newsletter
Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.