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Recall of two batches of NeoMercazole 20mg Tablets (Batch Numbers WE0140 & WE0141)

Notice type: Recall

Date: 13/12/2002

  

Product name or type:
NeoMercazole 20mg Tablets

Authorisation Number:
PA 50/121/2

Active Substance:
Carbimazole Ph. Eur

Serial Or Batch Number And Expiry Date:
Batch numbers: WE 0140 and WE0141

Target Audience:
Healthcare Professionals and Patients

Problem Or Issue:
The Irish Medicines Board wishes to advise of the recall of two batches of NeoMercazole 20mg Tablets (Batch Numbers WE0140 & WE0141) in which approximately 1 in 5 tablets are subpotent by up to 50% of the nominal dose. 

This information has already been communicated to Pharmacists and Medical Practitioners by letter. 

Subpotent Carbimazole Ph. Eur., (the active ingredient in NeoMercazole 20mg Tablets), could lead to undertreatment of patients with hyperthyroidism. However, under-therapy of carbimazole is likely to be clinically apparent from the patients' signs and subjective symptoms. Symptoms or signs of under treatment could be due to defective product not providing adequate blood concentrations of active drug rather than poor compliance or other reasons. 

Background Information Or Related Documents:
Recall of two batches of NeoMercazole 20mg Tablets (Batch Numbers WE0140 & WE0141) Document

Actions To Be Taken:
Patients who are currently taking NeoMercazole (especially those taking the above batches) should be monitored regularly for symptoms and signs of inadequate control of hyperthyroidism. Patients on NeoMercazole who may have concerns should contact their healthcare professional for advice. 

Doctors and pharmacists still holding product from the above batches should immediately withdraw them from use and contact Anne Bedford at Roche Customer Services on 01 4690700 to arrange for the uplifting of this stock and for free replacement with non-defective product. 

Further Information:
If you have any queries regarding this recall, please contact Anne Bedford at Roche Customer Services on 01 4690700.

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