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.