Genzyme recalls drug on failed stability testing
pharmafile | September 4, 2012 | News story | Manufacturing and Production |Â Â Genzyme, Stability Testing, pharma recallsÂ
Sanofi subsidiary Genzyme has recalled nine lots of its transplant drug Thymoglobulin in the US after stability testing revealed there may be a quality issue with the product.
The affected lots of Thymoglobulin (anti-thymocyte Globulin [Rabbit]) are all presented in 25mg vials and have expiry dates stretching from December 2012 to August 2013. A full list of the lots included in the recall is available on the US Food and Drug Administration (FDA) website.
“Genzyme has not identified any new safety risk to patients who have received Thymoglobulin from the implicated lot numbers, and there are no confirmed safety issues directly associated with the stability failure,” said the agency.
Thymoglobulin is a polyclonal antibody extracted from rabbit serum and is used to treat or prevent acute rejection in organ transplants as well as aplastic anaemia, and sales are estimated at around $250 million a year.
This is not the first time Thymoglobulin has been affected by stability issues. One lot of the product was recalled in 2008 for a similar reason, with the problem identified after visual inspection revealed an ‘opalescent’ appearance to the liquid in the vial.
The drug is made at Genzyme’s biomanufacturing facility in Lyon, France, with fill-and-finish operations taking place at it unit in Waterford, Ireland, so the issue appears to be separate to the remediation programme ongoing at the company’s Allston Landing facility in Boston, US.
Other recent US recalls
Noven Pharmaceuticals has been forced to recall various lots of its Daytrana (methylphenidate) patch for attention deficit hyperactivity disorder (ADHD) – equivalent to more than half a million units – because of defects in the product’s drug delivery system. Specifically, the defect affects patients’ ability to peel the back off the patch prior to sticking it onto the skin.
Hospira has recalled yet another injectable drug, this time almost 80,000 units of anticancer drug carboplatin in 10mg/ml vials, because of a failures in pH specifications. Earlier this month the company recalled one lot of its Carpuject (hydromorphone) injectable painkiller.
Teva recalled one lot (6,500 cartons) of its multiple sclerosis product Copaxone (glatiramer acetate) in the US after a customer complained of contamination with foreign particles in a single vial of the product.
Phil Taylor
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