During a routine quality examination of retention samples at the company’s Unterach facility in Austria, particulate matter was discovered in vials of its Methotrexate Sodium injectable.
Speaking with In-Pharmatechnologist.com, Sandoz spokesman Chris Lewis said the company was still investigating the root cause of the contamination.
“Preliminary results indicate that the particulates found were composed of silicon and cellulose,” he said.
Methotrexate was originally developed and continues to be used for chemotherapy, but is also used in the treatment of neoplastic diseases, severe psoriasis, and rheumatoid arthritis.
The recall, conducted in accordance with the US Food and Drug Administration (FDA), affects Injectable Vials of 25mg/mL and 40mL distributed across the US as well as to Poland.
Though Sandoz – a subsidiary of pharma giant Novartis – has said it is unaware of any adverse effects stemming from this manufacturing issue, it did warn of potential health risks to patients including microembolisation in areas where the particles lodge, such as the lung in the case of intravenous injections.
In 2011, three of Sandoz’s manufacturing sites were cited by the FDA for cGMP violations . The affected plants were Boucherville, Canada and Wilson and Broomfield in the US (North Carolina and Colorado, respectively).
The news comes just a day after fellow Germany head-quartered company, Boehringer Ingelheim, received an FDA warning letter after the company failed to discover the source of particle contamination at one of its API and pharmaceutical facilities.