Penn Pharma recalls batches of seizure drug

Following incorrect placement of screw caps on some units of Midazolam buccal liquid, which could affect drug concentration

Three batches of a drug to stop seizures, Midazolam buccal liquid 10mg, 1ml, 5ml, manufactured by UK CMO Penn Pharma are being recalled over packaging concerns.

The recall, by the Medicines and Healthcare Regulatory Agency (MHRA), affects batch numbers 008442, 009243 and 009259, which were distributed between February and July this year.

The MHRA said the batches are being recalled because the screw caps on some units had 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,' the MHRA said.

The Agency advises recipients to quarantine any product from this batch remaining within their control.

The drug was packaged by Tredegar, South Wales-based Penn Pharma for another UK firm, specials supplier Quantum Pharmaceutical, based in Burnopfield, County Durham.

Quantum said it has a list of all customers who have received these batches and will contact them with details of the number of units supplied so that they can be recalled.

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