Lupin Recalls 42 Lots of Ceftriaxone for Injection

JANUARY 07, 2019
Lupin Pharmaceuticals, Inc. has voluntarily recalled 42 of lots of Ceftriaxone for Injection, USP products at the hospital/physician level. These products were found to contain visual grey particulate matter in reconstituted vials.

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. The Lupin recall includes 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.

Improper piercing and use of a needle greater than 21 gauge, while reconstituting the vial, can push rubber flecks into the solution. There were no grey flecks seen prior to the reconstitution of the vials, and the issue was identified upon standard visual inspection prior to patient administration.

If injected, products 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.

Lupin’s recalled lots were distributed nationwide, according to the FDA. To date, the Company has not received any reports of adverse events related to the recalled lots.

Ceftriaxone for Injection, USP, is packaged in a glass vial, in pack 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.

A full list of recalled lot numbers is available on the FDA website.

Hospitals and physicians that have recalled Ceftriaxone for Injection, USP should stop using these products and return to Genco Pharmaceuticals Services “a subsidiary of FedEx Supply Chain” 6101 North 64th Street, Milwaukee, WI 53218, Tel: (855) 838-5786.


Reference

Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g [announcement]. Silver Spring, MD; January 5, 2018: FDA website. https://www.fda.gov/Safety/Recalls/ucm629298.htm?rel=0" ?rel=0" . Accessed January 7, 2018.


 

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