Midazolam recalled over increased strength fears
Three batches of the antiepileptic are being recalled due to concerns that a faulty screw cap on some of the 5ml containers could allow the drug’s aqueous component to evaporate and increase its concentration
The MHRA has urged pharmacists to contact patients who have been supplied batches of an antiepileptic drug over fears its strength could have increased.
Three batches of midazolam 10mg in 1ml buccal liquid are being recalled due to concerns that a faulty screw cap on some of the 5ml containers could allow the drug's aqueous component to evaporate and increase its concentration, the MHRA said yesterday (July 16).
Distributor Quantum Pharmaceutical was contacting all customers who had received the batches and would supply replacement stock for free, the MHRA said. This may be from a different manufacturer, it highlighted.
Pharmacists should quarantine remaining product from affected batches and contact patients "promptly" to check whether they were in possession of product from an affected batch, the MHRA said.
Patients should not return the drug until replacement stock was available, the MHRA stressed.
Pharmacists who have received affected stock and not heard from Quantum Pharmaceutical should contact the manufacturer on 08000 433134 or email [email protected]. Medical information queries should be directed to the same number.
The affected batches are:
Batch number |
Expiry date |
Pack size |
First distributed |
008442 |
October 2015 |
1 x 5ml |
Feb 5, 2014 |
009243 |
October 2015 |
1 x 5ml |
June 17, 2014 |
009259 |
October 2015 |
1 x 5ml |
July 7, 2014 |
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