05 March 2013
Class 2 medicines recall
Action within 48 hours
Pharmacy, wholesaler and clinic-level recall
Montelukast 5 mg Chewable Tablets
|Batch number||Expiry date||Pack size||First distributed|
|8009003||November 2014||1 x 28 tablets||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 firstname.lastname@example.org alternatively please contact Mylan Customer Services on 01707 853100 or email email@example.com.
For medical information enquiries please contact Mylan Medical Information on 01707 853000 or email firstname.lastname@example.org.
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.
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
Healthcare Commission for distribution to Independent health care establishments
Primary care trusts (England)