E-DRUG: WHO Alert 4/2015: Diazepam falsified Central Africa CRM:0003123
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Please find attached an important alert concerning
falsified diazepam tablets circulating in Central Africa. Please forward
this information to the National Regulatory Authorities, the procurement
centres/departments and any other relevant colleagues and organizations.
WHO are calling for increased vigilance for these specific batches of this
product.
This alert is available on the WHO website showing pictures of the relevant products:
http://www.who.int/medicines/publications/drugalerts/en/
If you have any question concerning these batches or if you wish to report
incidents concerning falsified medicines please contact rapidalert@who.int
WHO Alert follows:
Medical Product Alert No. 4/2015
Adverse reactions caused by Falsified Diazepam in Central Africa
This Medical Product Alert relates to the confirmed circulation of falsified versions of Diazepam
tablets circulating in Central Africa.
Since December 2014, over 400 patients in the north east region of the Democratic Republic of Congo
(DRC) have suffered from an acute dystonic reaction affecting the muscles of the face, neck and
tongue. This reaction usually lasts, without treatment, for between 3 to 4 days, sometimes re-occurs,
and has resulted in up to 40 hospital admissions per week. A detailed investigation carried out in DRC
has revealed that patients had been taking Diazepam to treat a wide range of illnesses.
PRODUCT ONE
Laboratory analysis of a product labelled as Diazepam has shown that it does not contain Diazepam,
but contains between 10mg to 20mg of Haloperidol per tablet.
Haloperidol is an antipsychotic and is used primarily for the treatment of schizophrenia, and one of
the known side effects is acute dystonic reactions affecting the face and neck. So far, all known
patients suffering a reaction have recovered. However the levels of Haloperidol present in the tablets
represent a serious risk particularly to the young.
The details of this product are as follows:
The tablets are light yellow in colour and are scored across the centre of the tablet on one side and
bear the letters AGOG on the other side.
AGOG is a pharmaceutical manufacturer. They have stated that they manufacture Haloperidol tablets
which are yellow in colour and bear the letters AGOG, but it is supplied in blisters of 10 tablets and
boxes of 10 blisters under the trade name AGOHAL, Haloperidol tablet BP 10mg. AGOG Pharma Ltd
have stated that they do not manufacture Diazepam.
The tablets that tested positive for Haloperidol were contained in white plastic bottles of 1000 tablets
and marked with the trade name SOLINA and Diazepam Tablets BP 5 mg manufactured by
CENTAUR Pharmaceuticals Ltd.
Trade Name: SOLINA
Product: Diazepam BP 5 mg
Batch Number: SBG038
Manufacturing Date: Sep 2014
Expiry Date: Aug 2017
CENTAUR pharmaceuticals have confirmed that they manufacture Diazepam and that the batch
number, and dates of manufacturing and expiry are correct as shown on the packaging.
CENTAUR pharmaceuticals have stated that they do not manufacture Haloperidol. The tablets
contained in the plastic bottles were not manufactured by CENTAUR pharmaceuticals and do not
contain diazepam The plastic bottle is stamped in red ink Government of Uganda. For public use
only, not for sale.
This product is circulating in the Ituri Health District of the Democratic Republic of Congo and the
adverse reactions have been focused in the vicinity of Nono.
WHO are requesting urgent vigilance for these tablets and careful examination of the contents of
bottles marked SOLINA, Diazepam 5mg, as they should not contain tablets marked with the lettering
AGOG.
PRODUCT TWO
The following version of falsified Diazepam is also circulating in the Democratic Republic of Congo
in containers of 1000 tablets. They are labelled as manufactured by AGOG Pharma Ltd, and again
contain yellow tablets bearing the lettering AGOG
AGOG pharma have confirmed that this packaging and labelling is falsified, and that they do not
manufacture Diazepam. The tablets have not yet undergone laboratory analysis, but on the basis of
confirmation that the labelling is falsified WHO request increased vigilance for the following batch:
Trade Name: DIAZPAM TABLETS
Product: Diazepam BP 5 mg
Batch Number: 2332
Manufacturing Date: Nov 2013
Expiry Date: Oct 2016
If you have any information concerning the supply of these products please contact
rapidalert@who.int
With kind regards
Rapid Alert Team | Michael Deats | Pernette Bourdillon Esteve |
SSFFC Global Surveillance and Monitoring Project |
Essential Medicines and Health Products | World Health Organization HQ
rapidalert@who.int
Hotline: +41 79 477 04 51
Carinne Bruneton <c.bruneton@remed.org>