Lupin recalls 42 lots of antibiotic after contaminate found in vials

By Maggie Lynch

- Last updated on GMT

(Image: Getty/westend61)
(Image: Getty/westend61)

Related tags Recall Fda Injection Antibiotics Inspection

Lupin Pharmaceuticals voluntarily recalling lots of Ceftriaxone for Injection after rubber flecks were found in vials.

The recall comes after Ceftriaxone for injection products have been found to contain visual grey particulate matter in reconstituted vials.

The five lots recalled contained Ceftriaxone for Injection, 250mg, 10 lots of Ceftriaxone for Injection, 500mg, 24 lots of Ceftriaxone for Injection, 1g, and three lots of Ceftriaxone for Injection, 2g.

Lupin stated that improper piercing and use of a needle greater than 21 gauge while reconstituting the vial can push rubber flecks into the solution.

No grey flecks were seen prior to the constitution of the vials. The issue was identified after standard visual inspection prior to patient administration.

The product containing rubber particulate matter could cause vein irritation or pulmonary embolic events potentially resulting in permanent impairment of bodily function if injected with the contaminant.

As ceftriaxone can be administered intramuscularly, the use of the product with its contaminant can cause local muscle inflammation and abscesses.

Ceftriaxone is a sterile, semi-synthetic, broad-spectrum cephalosporin antibiotic used to reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone sodium, and other antibacterial drugs.

Related news

Show more

Related products

State-of-the-Art Virtual Pharma Factory Tour

State-of-the-Art Virtual Pharma Factory Tour

Content provided by METTLER TOLEDO | 09-Jun-2023 | Event Programme

Join METTLER TOLEDO’s weighing experts on a virtual tour of a state-of-the-art manufacturing facility. On the call, you'll be digitally transported...

Understanding the hidden value of quality

Understanding the hidden value of quality

Content provided by Thermo Fisher Scientific – Production Chemicals and Services | 16-Jan-2023 | White Paper

The raw material supply is too vital to leave to chance, and quality-related supply chain activities are cornerstones to your success.

Follow us

Products

View more

Webinars