Pharmacy on Web

18 September 2008

The FDA has found a number of deficiences in the good manufacturing processes in two manufacturing sites of the India based pharmaceutical company Ranbaxy. 

The FDA has imposed an import ban, but not a recall of medicines, from these sites.


Subsidised medicines used in New Zealand from the Ranbaxy sites are:

-  Lovir tab (aciyclovir) 400mg and 800mg tab

-  Cefaclor 250mg cap and 125/5 susp

-  Amoxicillin 125/5 susp and 250/5 susp


There are 9 other medicines not funded by Pharmac and unlikely to be marketed or prescribed in NZ.  Details are on the attached Q&A link


Medsafe is assessing the situation and at this stage has not implemented a ban because
based on the information provided by the FDA there is no evidence to date of these
medicines being either unsafe or ineffective.  Both Medsafe and Pharmac at this stage are
taking precautionary steps to minimise a potential problem.


Please advise your patients not to stop taking these medicines as, to date, there is no
evidence of any danger.  If patients are not reassured with this advice then they could
consult their doctor for an alterative treatment.


For more information see the Ministry of Health media release
http://www.moh.govt.nz/moh.nsf/pagesmh/8391 and the questions and answers

http://www.moh.govt.nz/moh.nsf/pagesmh/8391/$File/ranbaxy-q-a.doc


FDA information is at http://www.fda.gov/bbs/topics/NEWS/2008/NEW01886.html

FDA consumer questions and answers at
http://www.fda.gov/cder/drug/infopage/ranbaxy/qa.htm

and the FDA warning letters to Ranbaxy at

http://www.fda.gov/foi/warning_letters/s6922c.htm

http://www.fda.gov/foi/warning_letters/s6923c.htm

Pharmaceutical Society of NZ