Gilead recalls Vistide on particle contamination
pharmafile | February 19, 2013 | News story | Manufacturing and Production |Â Â Gilead, VistideÂ
Gilead Sciences has issued a voluntary recall of one lot of its antiviral treatment Vistide after finding particulate matter in few vials of the drug.
The recalled lot of the Vistide (cidofovir) product was distributed to wholesalers, hospital and retail pharmacies in the US, Canada and Europe starting in October 2012.
In a statement, Gilead said that “particulate matter was found in some vials during packaging operations”, adding that an investigation has been initiated to identify the particles and determine the extent of the problem. A single lot (No. B120217A) is being recalled.
Vistide is indicated for the treatment of cytomegalovirus (CMV) retinitis in HIV-positive patients with acquired immunodeficiency syndrome (AIDS), an opportunistic infection which has become a lot less common since the advent of combination antiviral therapy for HIV-positive patients.
Gilead notes in its letter advising healthcare professionals of the recall that the effect of injecting particles can range from “no detectable clinical morbidity to allergic/anaphylactic reaction, tissue necrosis in one or more organs, stroke, myocardial infarction, respiratory failure, and loss of renal or hepatic function; which could result in death”.
It said there have been no product complaints in the past 12 months for Vistide in all markets.
Particulate contamination of sterile injectable products ranks second among the top 5 reasons for a Class I product recall in the US between 2008 and 2010, after sub or super-potent formulations.
Sometimes the particles are caused by drug constituents coming out of solution, but they can also be inorganic contaminants, such as glass, silicone and stainless steel, that have been introduced during the production process.
Phil Taylor
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