Drug Safety Alerts

Ceftriaxone for Injection Class I Recall

01/16/2019

On January 16, 2019, the United States Food and Drug Administration (FDA) issued a notice regarding a Class I recall of ceftriaxone for injection manufactured by Lupin Pharmaceuticals.This recall was issued due to repetitive product complaints indicating grey flecks in reconstituted vials.

A complete list of the affected products and lot numbers is provided here:

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. 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, 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.

Please note: This recall was originally issued on December 21, 2018 as a retail-level recall. The FDA classified this as a Class I Recall on January 16, 2019.

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. To date, the Company has not received any reports of adverse events related to the recalled lots.

CVS Caremark Response: These products are not carried by the CVS Caremark Mail Service Pharmacies.

For more information about this recall, health care providers may contact Lupin Pharmaceuticals Customer Service toll-free at 1‑866-587-4617 or visit www.lupinpharmaceuticals.com.

You may also contact the FDA consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332).

For more information regarding Ceftriaxone for Injection 250 mg, please click on the link below:

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=169899

For more information regarding Ceftriaxone for Injection 500 mg, please click on the link below:

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=169901

For more information regarding Ceftriaxone for Injection 1 g, please click on the link below:

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=169902

For more information regarding Ceftriaxone for Injection 2 g, please click on the link below:

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=169903