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[e-drug] Falsified batches of Postinor 2 recently discovered in Nigeria

E-DRUG: Falsified batches of Postinor 2 recently discovered in Nigeria
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OMS
20, AVENUE APPIA ? CH-1211 GENEVA 27 ? SWITZERLAND ?
Information Exchange System
Alert No. 128
Falsified batches of Postinor 2 recently discovered in Nigeria
http://www.who.int/medicines/publications/drugalerts/Alert_128_Information_P
ostinor_SP_26July.pdf

Background
In late June 2013 a batch of falsified Postinor 2 was discovered at Lagos
International Airport, Nigeria, containing no active pharmaceutical ingredient.

Postinor 2 is an emergency contraceptive (0.75mg levonorgestrel). The
genuine product is manufactured by Gedeon Richter and is a widely used WHO
pre-qualified medicine.

Two large boxes containing 150,000 doses of Postinor 2 were discovered at
Lagos International Airport by the Nigerian Agency for Food and Drug
Administration and Control (NAFDAC). The first box contained thousands of
Blisters containing 2 x tablets of Postinor 2 in each. The second box
contained the outer boxes and patient information leaflets.

WHO were informed on the 3rd July 2013 and subsequently contacted Gedeon
Richter. Samples were sent by WHO to a Forensic laboratory for further
analysis, where it was established that the tablets contained no active
pharmaceutical ingredient (levonorgestrel).

Suspect medical product
The details of the falsified batch of Postinor 2 is as follows.
Batch number: T13073C
Expiry Date: 03.2017
Manufacturing Date: 03.2012
The packaging is in English and bears a falsified stamp of the Nigerian
Agency for Food and Drug Administration , NAFDAC.
The batch number is a genuine Gedeon Richter Batch number, but the expiry
date and date of manufacture are falsified.

Gedeon Richter have informed WHO that falsified batches of Postinor 2 have
previously been found in Africa:
Ghana  April 2011 Batch Number T54365E
Kenya  June 2011 Batch Number T99128L
Angola  November 2012 Batch Number T12104B Page 2

Advice
Increased vigilance throughout the supply chain is strongly advised for
these batches. Postinor 2 should only be obtained from trusted, reliable and
established legal sources.
If you have any questions or further information concerning this batch, or
any is found or reported in your country, please contact rapidalert@who.int

Carinne Bruneton <c.bruneton@remed.org>

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