Alert from The U.S.Food & Drug Administration
Recall Voluntary
Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g
- The products have been found to contain visual grey particulate matter in reconstituted vials
- Improper piercing and use of a needle greater than 21 gauge (larger internal diameter), while reconstituting the vial, can push rubber flecks into the solution
If injected, this 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
Ceftriaxone for Injection, USP, is used as a sterile, semi-synthetic, broad-spectrum cephalosporin antibiotic for intravenous or intramuscular administration. It is used to reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone sodium and other antibacterial drugs Ceftriaxone for Injection, USP, should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria
The lots of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g included in the recall are extensive and the FDA website should be consulted for the specific lot number identifiers effected by the recall
