Montelukast 5 mg Chewable Tablets – error on the carton
- The problem
- (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)
- 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.
05 March 2013
Class 2 medicines recall
Action within 48 hours
Pharmacy, wholesaler and clinic-level recall
MDR 01-01/13
Product details
Mylan
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 laura.ainslie@mylan.co.uk alternatively please contact Mylan Customer Services on 01707 853100 or email mguk_edi_orders@mylan.co.uk.
For medical information enquiries please contact Mylan Medical Information on 01707 853000 or email info@mylan.co.uk.
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
Updated 5 March 2013. This page summarises an official notice. Details can change – always follow the official notice.