ALK Product Portfolio Not Affected by Glass Delamination Recall
ROUND ROCK, Texas, July 23, 2013 /PRNewswire/ -- A recent recall by a major manufacturer of Albumin Saline with Phenol (ABS) and Normal Saline with Phenol (NSP) products due to glass delamination has led to inaccurate claims of an "industry wide" recall of injectable pharmaceutical products in the allergy industry. ALK, a leading company focusing on allergy treatment, is pleased to announce that the entire ALK portfolio of products is not affected by this recall.
ABS and NSP are used as diluents with allergenic extracts to create customized immunotherapy treatments for patients. Various companies supply glass products to the pharmaceutical industry, but only one supplier has experienced glass delamination issues at this time. According to the Food and Drug Administration, glass delamination occurs when small volume vials shed thin, flexible glass fragments into the solution. http://1.usa.gov/15GEd1i
"ALK does not use the glass products from the manufacturer that has experienced the problem of glass delamination," said Jorge Alderete, ALK Senior Vice President of Commercial Operations. "This recall is isolated to a single glass vendor, and is not what ALK would consider to be an 'Industry Wide' issue. ALK takes this issue very seriously, and after thoroughly researching the issue through our scientific, quality, and regulatory departments, ALK is pleased to report our vials do not exhibit glass delamination and ALK has sufficient product available to meet patient needs."
ALK is a research driven, global pharmaceutical company focusing on allergy treatment, prevention and diagnosis. As the world leader in allergy immunotherapy, a treatment given to increase immunity to substances causing allergic symptoms, ALK is devoted to improving the quality of life for people with allergies by creating products that treat the cause of allergies. ALK and the Asthma and Allergy Foundation of America have partnered to create a unique online resource on allergy immunotherapy for patients: www.fightthecauseofallergy.org ALK is also committed to supporting the business of allergy by providing diagnostic tools, automation software and customized business, technical and clinical consulting services.