E-drug: Products recalled in Australia
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Dear e-druggers,
For those of you with an interest in regulation and licensing
issues, you may be interested to follow events in Australia at the
moment. The Therapeutic Goods Administration has suspended
the licence of a pharmaceutical manufacturing company, which
has resulted in over 700 products being recalled. Below is the
media release from the Therapeutic Goods Administration.
Media release:
National Medicines Regulator Suspends Drug Company's
Manufacturing Licence Monday 28 April 2003
The Commonwealth medicines watchdog, the Therapeutic
Goods Administration (TGA), has suspended the licence held by
Pan Pharmaceuticals Limited of Sydney to manufacture
medicines after TGA inspectors found a series of serious safety
and quality breaches by the company. These included
substitution of ingredients, manipulation of test results and
substandard manufacturing processes. In addition the regulator
has ordered an urgent recall of 219 products which Pan
Pharmaceuticals manufactures and supplies in Australia, with a
potential for a larger recall within days. It is stressed that, up to
this time, no safety problems have been identified with
prescription medicines supplied as Pharmaceutical Benefits
Scheme items. These medicines have been assessed
thoroughly by the TGA and all people may continue to take their
Pharmaceutical Benefits medicines without concern. Pan
Pharmaceuticals is Australia's largest contract manufacturer of
complementary medicines such as herbal, vitamin, mineral and
nutritional supplements. They also manufacture some
over-the-counter (OTC) medicines including pain relievers
(paracetamol & codeine) and cold and flu preparations
(antihistamine & pseudoephedrine).
Other companies also use Pan Pharmaceuticals to manufacture
their own brand products and the TGA will be working with these
companies to identify which other products should be subject to
recall. The action by the TGA today follows advice received from
an expert advisory group convened to give an independent
evaluation of the TGA findings. The group, chaired by Dr
Richard Whiting, Chairman of the Medicines Evaluation
Committee, reviewed the audit reports and advised that the
quality and safety concerns posed by the manufacturing
breaches at Pan Pharmaceuticals needed to be urgently
addressed. Acting on that advice the TGA has suspended the
company's licence with an immediate effect to protect the health
and safety of the Australian community. This is not the first
action taken against Pan Pharmaceuticals. In January this year
an anti-travel sickness tablet, Travacalm manufactured by Pan
Pharmaceuticals for another company, was the subject of a
consumer recall. Faulty batches of the tablets were responsible
for 19 people being hospitalised and 68 others experiencing
potentially life threatening adverse reactions to this
over-the-counter medicine. Subsequent laboratory testing by the
TGA of some of the tablets revealed that one of the active
ingredients - hyoscine hydrobromide - varied in content from 0 -
700% of the listed dose.
The company's manufacturing licence was immediately
restricted to prevent the manufacture of Travacalm tablets and
similar microdose products. The TGA undertook further audits of
the company which also revealed serious deficiencies in the
company's manufacturing and quality control procedures,
including systematic and deliberate manipulation of quality
control test data.
The TGA's Principal Medical Adviser, Dr John McEwen, said the
TGA has a responsibility to protect the health of all Australians
and, as the regulator of medicines, is obligated to take action
where there is a concern that consumers might be at risk
because of sub-standard products. "Manufacturers of medicines
must comply with strict standards, so that consumers can be
confident of the quality and safety of the medicines they take,"
he said.
Some examples identified by the audit included:
* On 13 March 2003 the status of 270 raw materials was
changed in the company's computer from Quarantine to Pass.
In a random sample of these, none had been tested. It has been
clearly identified that some were used in manufacture but not
tested by the time of the audit on 14 April 2003. For example, 7
of these raw materials were used in the manufacture of 34
batches of products.
* Four recent examples of manipulation of the assay results of
finished products in order to comply with specifications. These
occurred between October 2002 and 22 January 2003 and
involved an "energy" product, a vitamin product and a cough
and cold formula.
* Four recent examples of the fabrication of finished product
assay results of a vitamin product for export in order to comply
with specifications. In two instances the product was
over-strength (March 2003); in the other two under-strength.
* In the past two and a half years, several instances of the use
of beef cartilage in place of shark cartilage and one instance of
use of shark cartilage in place of beef cartilage.
* Five instances where products were released and dispatched
in the period 24 March 2003 to 31 March 2003 without
completion of the testing of the raw materials used.
Further information about the products being recalled and
products that may be manufactured by Pan Pharmaceuticals Ltd
under other brands, visit the TGA website on
www.tga.health.gov.au or phone the toll-free number 1800 220
007 (hours 8am - 8pm seven days a week).
Kind regards,
Libby Roughead
School of Pharmaceutical, Molecular and Biomedical Sciences,
University of South Australia
GPO Box 2471
Adelaide, 5001
South Australia
Phone: +61 8 8302 2179
Fax: +61 8 8302 2389
E-mail: libby.roughead@unisa.edu.au
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