The Inspectorate and Enforcement Directorate within the Medicines Authority has withdrawn a batch of Cilest® tablets due to a reported slower than expected solubility of an active ingredient.
The authority cobducted the recall after it was informed that Janssen-Cilag International NV is initiating a voluntary preventative product recall of Cilest® 250/35 Oral Contraceptive Tablets (250μg norgestimate 35μg ethinyl estradiol).
According to the authority, this can potentially lead to decreased contraceptive effect. It has been reported that the likelihood of patients experiencing an adverse affect due to this appears to be very low.
Stock of Cilest® will be withdrawn from pharmacies.
Patients are requested to contact their doctor to be advised regarding the continuation of their treatment.
For more information, one is being advised to phone on 2343 9000.