Par recalls product after glass particulate contamination

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Shidlovski)
(Image: Getty/Shidlovski)

Related tags: Endo International, Par Pharmaceutical, Fosun Pharma, Gland Pharma, Recall

Par Pharmaceutical initiates a recall of mycophenolate mofetil injection, after a vial containing a glass fragment was discovered during reconstitution.

The voluntary recall involves only a single lot of mycophenolate mofetil for injection, which was delivered to the US hospital and retail pharmacy level in January and February 2019.

Within the recall announcement, the dangers of administration of the product containing glass particulate included local irritation and swelling.

The statement further stated, “More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening.”

At present, Par Pharma noted that it has not received any reports of adverse events.

In a particularly complicated chain of provenance, Par Pharma is a US-based subsidiary of Irish company, Endo International​, which in turn received the mycophenolate mofetil injection product from Gland Pharma – the latter company is based in India and is itself a subsidiary of China’s Fosun Pharma, after it acquired Gland Pharma​ in a $1.1bn (€912.6m) deal.

Mycophenolate mofetil for injection is used for the prevention of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants, alongside doses of cyclosporine and corticosteroids.

Par Pharma stated it would be providing written notification of the recall to national wholesale accounts and direct customer locations.

The company will work with Inmar to return the recalled product.

Related topics: Regulatory & Safety, Regulations, QA/QC

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