After finding grey particulate matter in reconstituted vials, Lupin Pharmaceuticals, Inc. issued a voluntary recall to the hospital/physician level of 5 lots of Ceftriaxone for Injection, USP, 250 mg; 10 lots of Ceftriaxone for Injection, USP, 500 mg; 24 lots of Ceftriaxone for Injection, USP, 1 g; and 3 lots of Ceftriaxone for Injection, USP, 2 g.
Incorrect piercing and using a needle greater than 21 gauge while reconstituting the vial can force rubber flecks from the stopper into the solution. There were no grey flecks seen prior to reconstitution of the vials.
Injecting ceftriaxone (with the rubber particles) could result in vein irritation/phlebitis or pulmonary embolic events that could lead to permanent impairment of body function or damage to, for example, the lungs and vascular system. Also, as the drug can be administered intramuscularly, its use may cause local muscle inflammation and/or abscesses.
Ceftriaxone for Injection, USP, is a sterile, semi-synthetic, broad-spectrum cephalosporin antibiotic for intravenous or intramuscular administration. It is used to decrease the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone sodium and other antibacterial drugs. The drug should be used to treat or prevent only those infections either proven or believed to be caused by bacteria.
Ceftriaxone for Injection, USP, is packaged in glass vials, in packs of 10, containing 10 vials in a carton, with NDC 68180-611-10, 68180-622-10, 68180-633-10, 68180-644-10 and as single pack containing one glass vial in a carton with NDC 68180-611-01, 68180-622-01, 68180-633-01.
Lupin Pharmaceuticals Inc. is notifying distributors and arranging for the return of all recalled product lots. The recall is being conducted with the knowledge of the FDA.
Source: Drugs.com, January 5, 2019