* All retail supplies recalled in U.S. and Puerto Rico
* European sales of Alli unaffected by move
* Company investigations ongoing
(Adds background on drug, detail on reported tampering, further
By Ben Hirschler
LONDON, March 27 GlaxoSmithKline is
recalling all supplies of its non-prescription weight-loss drug
Alli in the United States and Puerto Rico after customers
reported finding other pills and tablets in some bottles.
The news is a fresh blow for a product once touted as a
potential blockbuster but which has had disappointing sales over
the years - aggravated, in part, by a separate supply problem
two years ago.
The British group said it believed that some U.S. bottles of
Alli might not contain authentic product, adding that it was
working with the U.S. Food and Drug Administration on the
News that bottles had been tampered with first emerged on
GSK has received inquiries from consumers in Alabama,
Florida, Louisiana, Mississippi, New York, North Carolina and
Texas about 20 bottles containing tablets and capsules that were
The treatment is also sold in Europe but the company said no
problems had been detected there and European sales were not
affected by the U.S. recall.
GSK said it was not immediately clear how the bottles had
been tampered with or where in the supply chain the problem had
NO THEORIES YET
"The investigation is ongoing. We've asked people to return
bottles to us, so we can examine them very closely ... we don't
have any theories at this point," a company spokeswoman said.
Shoppers said they had found a range of tablets and capsules
of various shapes and colours in purchased Alli containers. The
authentic drug is a turquoise-blue capsule. Some bottles inside
the outer carton were also missing labels and had tamper-evident
seals that were not genuine.
There have been no reports of any serious illnesses related
to the product after news of the tampering.
Quality problems have become a big issue in the
pharmaceuticals industry, with most attention focused on Indian
generic prescription drug suppliers. However, Western gtoups
such as Johnson & Johnson have also suffered failures in
Alli is marketed by GSK's consumer healthcare business and
is approved for over-the-counter (OTC) sale for overweight
adults, in conjunction with a low-fat diet.
The treatment, which is a low-dose version of Roche's
Xenical, was launched in the United States in 2007 with
a big marketing campaign. But the product has failed to achieve
the $500 million to $1 billion of sales analysts had initially
GSK no longer breaks out Alli sales figures, though revenue
from the product was 93 million pounds ($154 million) in 2011.
The company tried to sell the Alli brand that year, along
with a number of other non-core OTC healthcare products, but its
divestment was scrapped after an interruption in supplies from
Roche, which makes the active ingredient for the drug.
($1 = 0.6037 British Pounds)
(Editing by David Goodman)