Canesten Pessary – 2 batches have wrong patient information leaflet
- The problem
- (Bayer Consumer Care Division) Two batches inadvertently placed on the market containing patient information leaflet (PIL) for prescription only medicine (POM) product - class 4 caution in use. (EL(11)A/17)
- What to do
- Check the batch number on your pack against the list below. Do not stop taking a prescribed medicine without talking to your pharmacist, GP or prescriber first – they can check your supply and swap it if needed.
21 June 2011
Class 2 medicines recall
Action within 48 hours
Pharmacy-level recall
MDR 51-06/11
Product details
Bayer plc, Consumer Care Division
Canesten Pessary, legal status ‘P’
Clotrimazole 500mg
PL 00010/0083
Alert details
- Batch number: BXFWKG1
- Expiry date: 31 Mar 2016
- Pack size: 1×1
- First distributed: 16 May 2011
- Batch number: BXFTDV1
- Expiry date: 31 Jan 2016
- Pack size: 1×1
- First distributed: 14 Jun 2011
Bayer plc, Consumer Care Division is recalling the above batches because they have inadvertently been placed on the market containing the patient information leaflet (PIL) intended for the ‘POM’ product. The PIL for the ‘P’ pack includes additional safety warnings and precautions which are not present in the ‘POM’ leaflet. ‘P’ products are available in a pharmacy without prescription, under the supervision of a pharmacist, hence the requirement for additional safety information on the PIL.
Pharmacists are asked to quarantine any remaining stock of these batches and return it to the wholesaler from which it was originally obtained.
For stock enquires, please contact your wholesaler or original order point. For medical information enquiries please contact Bayer Medical Information on 01635 563232.
Recipients of this drug alert should bring it to the attention of relevant contacts by copy of this letter. Primary care trusts are asked to forward this to community pharmacists.
MHRA distribution
Further recipients by cascade:
Regional contacts for NHS trusts and provider units
Chief Pharmacists: England, Scotland, Wales, Northern Ireland
Prison Health Policy Unit (DH)
Chief Pharmacists: Jersey, Guernsey, Alderney, Sark, Isle of Man, Gibraltar
Special hospitals
Healthcare Commission for distribution to independent health care establishments
Primary Care Trusts (England)
Download documents
Updated 21 June 2011. This page summarises an official notice. Details can change – always follow the official notice.