Inspections, Compliance, Enforcement, and Criminal Investigations

GlaxoSmithKline Update on Stolen Advair

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Issued: Date Friday, 16 July 2010 Research Triangle Park, NC

A small number of Advair Diskus inhalers stolen from a GlaxoSmithKline distribution warehouse in 2009 have been found in some pharmacies. The safety and effectiveness of the stolen inhalers cannot be assured and they should not be used.

Advair Diskus (fluticasone propionate and salmeterol inhalation powder) is an inhaler used to treat patients with asthma and chronic obstructive pulmonary disease.

The products were reported stolen in August 2009 from a GlaxoSmithKline warehouse near Richmond, Va. The inhalers found recently were the first from the stolen lots to be found in commerce. However, more stolen product may still be on the market and GSK continues to work with the FDA to aggressively investigate the matter.

Medicine in the stolen cartons could represent a health risk because it has been removed from the legitimate supply chain. The product may have been tampered with 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, doses, and expiration dates of the stolen Advair Diskus inhalers are:

Lot 9ZP2255 - NDC 0173-0696-00, Advair Diskus 250/50, 60 Dose – Exp: Sep 2010
Lot 9ZP3325 - NDC 0173-0697-00, Advair Diskus 500/50, 60 Dose – Exp: Sep 2010

Pharmacists and wholesalers who find Advair Diskus inhalers bearing these lot numbers should remove them from shelves and contact the FDA’s Office of Criminal Investigations (OCI) at 800-551-3989. The agency also is asking for the public's help in reporting any information regarding these inhalers, including suspicious or unsolicited offers for the Advair Diskus lots in question, to OCI or by visiting the OCI website at www.fda.gov/oci.  Inquiries for the company should be directed to GlaxoSmithKline’s Customer Response Center at 888-825-5249.

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 further information go to us.gsk.comdisclaimer icon, follow us on twitter.com/GSKUSdisclaimer icon or visit our blogdisclaimer icon (www.morethanmedicine.us.gsk.com/blog/disclaimer icon).

Inquiries:    
US Media Inquiries: Nancy Pekarek (919) 483 2839
  Mary Anne Rhyne (919) 483 2839
  Kevin Colgan (919) 483 2839
  Sarah Alspach (919) 483 2839
     
US Analyst/ Investor Inquiries: Tom Curry (215) 751 5419
  Jen Hill Baxter (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 2009.

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

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