- Medicines and Healthcare products Regulatory Agency
- 16 July 2014
- Alert type:
- Drug alert
- Medical specialty:
(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
Penn Pharma, distributed in Quantum Pharmaceutical livery
Midazolam Buccal Liquid 10mg / 1ml, 5ml
Unlicensed medicine made under Manufacturers Specials Licence
|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 firstname.lastname@example.org.
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.
Issued: 16 July 2014
Alert type: Drug alert
Medical specialty: Pharmacy