Regulatory & Safety

Seizure treatment “special” recalled in UK after packaging problems

17-Jul-2014
Last updated on 17-Jul-2014 at 17:14 GMT - By Gareth MacDonald+
Unlicensed, "special" formulation of Midazolam recalled after CMO packaging problems
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Three batches of the seizure drug midazolam made by UK CMO Penn Pharma are being recalled over concerns that packaging problems may affect its concentration.

The recall – which was announced on the UK Medicines and Healthcare Regulatory Agency (MHRA) site last night – affects three batches of midazolam buccal liquid – 008442, 009243 and 9259 – that were distributed between February and July this year.

The notice explains that the recall was initiated because “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.”

The drug was made by contract manufacturing organisation (CMO) Penn Pharmaceuticals for fellow UK-based firm Quantum Pharmaceutical, which is a supplier of unlicensed drugs or “specials.”

An MHRA spokesman told us “Our Defective Medicines Reporting Centre (DMRC) was informed of an issue by Penn Pharmaceuticals and recall was agreed with the company.

For licensed products the MAH is responsible for recalls, however, in the case of this unlicensed special Penn Pharmaceuticals are responsible for recall and they are using their UK distributor for this product, Quantum Pharmaceuticals, to carry out the recall.” 

Recall and replacement

Burnopfield, County Durham-based Quantum said it has a list of all customers who have received midazolam from the affected batches, adding that it “will provide replacement stock free of charge.” 

Remarkable PR, which represents Penn, told us the firm had no comment when we asked for details of the manufacturing issues and whether the problems at the CMO’s plant in Tredegar were likely to have affected other customers.

A Quantum spokesman told us the firm has “cooperated fully with the MHRA, the DMRC and the manufacturer, Penn Pharma, to resolve this promptly with minimum disruption to patients, pharmacies or prescribers.”

We had already begun providing patients with replacement product before the MHRA recall was announced and have been praised for our prompt and proactive response.”

He added that: "We manufacture as many specials as possible in-house, however, buccal medication requires specific technology and for this reason we have it manufactured on our behalf by Penn Pharma" and confirmed that Penn supplied the replacement midazolam.

Related topics: Regulatory & Safety, QA/QC, Delivery formulations