update - Epipen manufacturer Meridian Medical Technologies completes investigation

Meda recalls EpiPen batch in Denmark after reports of defects

By Gareth Macdonald

- Last updated on GMT

istock/Roel Smart
istock/Roel Smart

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Mylan subsidiary Meda has recalled a batch of EpiPens in Denmark after reports some have defective auto-injectors.

The product withdrawal – which was detailed​ on the Danish Medicines Agency (DKMA) – covers 499 Epipens (epinephrine injection, USP) from batch number 5FA665B, which Meda had intended to sell in Denmark.

The DKMA said: “The withdrawal follows from two reports of a defective EpiPen with this batch number. Against this background, there is a low risk that EpiPen does not work in rare cases.

Consequently, there is a low risk that patients who experience a severe hypersensitivity reaction cannot treat themselves with an adrenaline injection​.”

This was confirmed by Meda spokeswoman who told us "Meda initiated the voluntary recall after receiving two reports of failure to activate the device due to a possible defect. The recall is a precautionary measure."

She added that: "The recalled product was manufactured by Meridian Medical Technologies in the US​.

"An investigation has been conducted by our manufacturing partner Meridian Medical Technologies and it has been observed that there may be a very small probability in lot 5FA665 that the auto-injector may not work correctly​."

No shortages

The recall is unlikely to result in shortages according to the DKMA, which said: “There are other product numbers and batches of EpiPen on the market that are not affected by this withdrawal​.”

Other firms that supply the Danish market include Orifarm and 2care4, both of which parallel import the product.

Meda began selling Epipen last year​ after it was acquired by Mylan.

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