UK - Class 2 Drug Recall for Midazolam Buccal Liquid 10mg/1ml x 5ml

17th of July 2014

A medicines recall for Midazolam Buccal Liquid 10mg/1ml, 5ml manufactured by Penn Pharma and distributed in Quantum Pharmaceutical livery has been issued.

The Class 2 drug alert is for the unlicensed medicine made under the Manufacturer's ‘Specials' Licence MS 4351 and relates to the following batches:

Batch number	Expiry date	Pack size	First distributed
008442	Oct 2015	1 x 5ml	05 Feb 2014
009243	Oct 2015	1 x 5ml	17 Jun 2014
009259	Oct 2015	1 x 5ml	07 July 2014

The MHRA says the recall is due to screw caps on some units not having been put on correctly during the manufacturing process. Potential evaporation could therefore increase the concentration of midazolam.

Quantum Pharmaceuticals has a list of customers who have received any of the affected batches and should be contacting them directly about the recall. Pharmacies are being asked to contact patients who have received the affected batches.

Quantum will replace any affected product free of charge, although this may not necessarily be made by Penn.

Patients should also not return any affected product until replacement stock is available to them, says the MHRA. Quantum Pharmaceutical Medical Information can be contacted on 08000 433 134 or recall@quantumpharma.co.uk