Lupin Pharmaceuticals, Inc. Recalls Ceftriaxone for Injection

January 7, 2019

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 announced on January 5, 2019 that Lupin Pharmaceuticals, Inc. is voluntarily 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 after visual grey particulate matter was found in reconstituted vials. The company states that rubber flecks from the stopper can be pushed into the solution when the use of a needle greater than 21 gauge and improper piercing occurs.

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 website. Products were distributed nationwide to wholesalers and drug chains. As of the date of the recall, the company had not received any reports of adverse events. Adverse events may be reported to FDA via the agency’s MedWatch program.

Source: FDA