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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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GSK Advisory: Advair Diskus theft

 

FDA posts press releases and other notices from firms as a service to consumers, the media, and other interested parties. 

Issued: Monday, 24th August 2009, Research Triangle Park, NC

 

GlaxoSmithKline is advising that two lots of Advair Diskus® (fluticasone propionate and salmeterol inhalation powder) medication were stolen on August 2 from the company’s distribution facility near Richmond, Virginia.  Medicine in the stolen cartons could represent a health risk because it has been removed from the legitimate supply chain and the storage conditions under which the stolen products were held are unknown.  Inhalers from these lots should not be dispensed, sold, or used.

 

The lot numbers and quantities are:

 

Lot 9ZP2255 - NDC 0173-0696-00, Advair Diskus 250/50, 60 Dose (14,400 inhalers)

Lot 9ZP3325 - NDC 0173-0697-00, Advair Diskus 500/50, 60 Dose (11,200 inhalers)

 

These lots were awaiting distribution to retail pharmacies at the time of the theft. Neither of these lots are part of the legitimate pharmaceutical supply chain.  GSK has alerted its distributors and customers to the stolen lots.

 

Anyone who has information regarding this incident, has received suspicious or unsolicited offers for the Advair Diskus lots in question, or has received product from these lots is encouraged to contact the U.S. Food and Drug Administration (FDA) Office of Criminal Investigations at 1-800-551-3989.  Patient or customer inquiries for the company should be directed to GSK’s Customer Response Center at 1-888-825-5249.

 

GSK discourages patients from purchasing any medication sold outside of legitimate channels.

 

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For more information please visit: www.us-gsk.com

 

Inquiries:

 

 

US Media Inquiries:

Patty Johnson

(919) 483 2839

 

 

 

US Analyst/ Investor Inquiries:

Tom Curry

(215) 751 5419

 

Jen Baxter Hill

(215) 751 7002

 

Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2007.

 

 

Five Moore Drive

P.O. Box 13398

Research Triangle Park, NC  27709-3398