Lupin Pharmaceuticals recalls injections due to visual gray material

If injected, the drug 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

Lupin Pharmaceuticals recalls injections due to visual gray material
Ceftriaxone for Injection USP (Source: medilineplus.gov)

LAKE CHARLES, LA (KPLC) - Lupin Pharmaceuticals, Inc. has voluntarily recalled several lots of injections due to visual gray material found in products, according to the FDA.

The lots affected include:

  • 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

Ceftriaxone for Injection, USP, is used as a sterile, semi-synthetic, broad-spectrum cephalosporin antibiotic for intravenous or intramuscular administration, FDA said. It is used to reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone sodium and other antibacterial drugs.

The FDA said some products have been found to contain visual gray particulate material 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 the contaminated products are injected, the drug 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, said the FDA. The use can also result in local muscle inflammation and/or abscesses.

Patients using the affected injections should discontinue and return it back to the company for reimbursement. No adverse reactions have been reported.

FDA said 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.

These products are sold nationwide. See a full list of drugs included in the recall HERE.

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