Canesten Pessary - 2 batches have wrong patient information leaflet

(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)

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    Expiry date    Pack size    First distributed
 BXFWKG1    31 Mar 2016    1x1    16 May 2011
 BXFTDV1    31 Jan 2016    1x1    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)

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