Midazolam Buccal Liquid 10mg / 1ml, 5ml - screw caps not been correctly placed

(Penn Pharma, distributed in Quantum Pharmaceutical livery) May result in evaporation of aqueous component of product and increase in concentration of Midazolam. (EL (14)/A10)

16 July 2014

Class 2 medicines recall

Action within 48 hours

Patient and pharmacy-level recall

MDR 06-07/14

Product details

Penn Pharma, distributed in Quantum Pharmaceutical livery

Midazolam Buccal Liquid 10mg / 1ml, 5ml

Unlicensed medicine made under Manufacturers Specials Licence

MS 4351

Alert details

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 above batches are being recalled because the screw caps on some units have not been correctly placed during manufacture. This may result in evaporation of the aqueous component of the product and a consequent increase in the concentration of Midazolam.

Recipients should quarantine any product from this batch remaining within their control. Quantum Pharmaceutical has a list of all customers who have received this batch and is in the process of contacting them with details of the number of units supplied. Pharmacists are being asked to contact patients who have received this batch promptly to check whether they have any stock in hand. Quantum Pharmaceutical will provide replacement stock free of charge. Please note that this may be from a different manufacturer. Patients should not return stock from batch 008442, 009243 or 009259 until replacement stock is available for them.

If you have received stock from batch 008442, 009243 and / or 009259 and have not been contacted by Quantum Pharmaceutical, please telephone them on 08000 433 134 or email recall@quantumpharma.co.uk.

For medical information enquiries, please contact Quantum Pharmaceutical Medical Information on 08000 433 134.

Recipients of this drug alert should bring it to the attention of relevant contacts by copy of this letter. Local area teams are asked to forward this to relevant clinics and community pharmacists.

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