Montelukast 5 mg Chewable Tablets - error on the carton

(Mylan) Carton incorrectly states "For children 2 to 5 years" but patient information leaflet (PIL) correctly states "For children 6 to 14 years" – class 2 action within 48 hours. (EL (13)A/08)

05 March 2013

Class 2 medicines recall

Action within 48 hours

Pharmacy, wholesaler and clinic-level recall

MDR 01-01/13

Product details


Montelukast 5 mg Chewable Tablets

PL 04569/1143

Alert details

  • Batch number: 8009003
  • Expiry date: November 2014
  • Pack size: 1 x 28 tablets
  • First distributed: 25 February 2013

Mylan are recalling all remaining packs of the above batch to pharmacy, clinic and wholesaler level, due to an error on the carton. The carton incorrectly states “For children 2 to 5 years” but the patient information leaflet (PIL) correctly states “For children 6 to 14 years”

Remaining stocks of the affected batches should be quarantined and returned to the original supplier for credit. For enquiries relating to stock returns please contact Laura Ainslie on 01707 853006 or by email at alternatively please contact Mylan Customer Services on 01707 853100 or email

For medical information enquiries please contact Mylan Medical Information on 01707 853000 or email

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 relevant clinics, general practitioners and community pharmacists for information.

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

Published 17 December 2014