20 November 2001
Ministry Of Health Consulted On Estelle-35 ED Recall
Women using the oral contraceptive Estelle-35 ED should make an appointment with their GP or Family Planning Clinic this
week after the pill was recalled by its manufacturer Douglas Pharmaceuticals Ltd.
Medsafe Senior Advisor Dr Stewart Jessamine said Douglas Pharmaceuticals Ltd recalled the oral contraceptive in
consultation with the Ministry of Health after a mistake occurred with the pill's packaging.
"Douglas Pharmaceuticals has reported there was one incident of a single white inactive tablet being present in place of
a yellow active tablet in the blister strip."
"The company informed the Ministry of Health on Friday 16 November as soon as it became aware of the problem and has
kept the Ministry informed of its plans and processes for the recall."
Estelle-35 ED is packed in a similar way to many oral contraceptives. There are 21 yellow active tablets and seven white
inactive tablets on each blister strip. The tablets have to be taken in the prescribed sequence.
Dr Jessamine said there was a small chance women taking Estelle-35 ED may become pregnant as a result of the packaging
problem. "There is a chance that an inactive pill taken within the first or last seven days of the active pill cycle
will reduce the contraceptive effectiveness of the product."
"Women are advised to continue taking the product but to take additional barrier contraceptive measures for the next
seven days or until they see a medical practitioner. During the consultation it may be appropriate that a test to be
performed in order to rule out pregnancy."
Dr Jessamine said Douglas Pharmaceuticals Ltd has made arrangements to reimburse patients for the consultation fees and
new prescription costs.
ENDS