Withdrawal of a batch of EpiPen® 300 micrograms

17 March 2017

MEDA recalls a batch of the adrenaline product EpiPen® 300 micrograms/dose, which is used for sudden allergic reactions. There is a risk that the auto-injector does not work. The withdrawal concerns product number 578818 with batch number: 5FA665B and expiry date 03/2017.

EpiPen® is an auto-injector (syringe) containing adrenaline designed for self-administration in acute serious hypersensitivity reactions (acute, severe anaphylaxis). 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.

In Denmark, the recalled batch includes 499 adrenaline pens. Unfortunately, patients cannot see whether the product is defective. Patients can check the batch number on the EpiPen® auto-injector.

Information about the defective batch on the Danish market:
Product number: 578818
Batch number: 5FA665B
Expiry date: 03/2017

There are other product numbers and batches of EpiPen® on the market that are not affected by this withdrawal. Please note that EpiPen® parallel imported by Orifarm and 2care4 are not affected by the withdrawal.

Patients are recommended to check the batch number, or ask relatives or the pharmacy for help. If the product has the batch number mentioned, you should go to your pharmacy as soon as possible and have it replaced by a new EpiPen®. If you experience a severe hypersensitivity reaction before you have had the pen replaced, you should use the EpiPen® – as instructed by your doctor. However, note that there is a low risk that the pen does not work. You are encouraged to avoid activities associated with an increased risk of severe hypersensitivity reactions.

If your product does not carry batch number 5FA665B, you do not need to take any further action.

Pharmacies are encouraged to help patients check the batch number. Products from the defective batch will be replaced, at no cost to patients, by a new EpiPen® until 31 March 2017, which is the expiry date of the product.

Doctors should pay attention to the withdrawal.

List of pharmacies that have received the affected batch number

About EpiPen®

EpiPen® is an auto-injector (syringe) containing adrenaline, which stimulates the heart and causes blood vessels to contract. The product is a first-line treatment for a sudden life-threatening allergic reaction (anaphylaxis). For example, an anaphylactic reaction triggered by insect stings or by food. An anaphylactic shock involves hypotension and breathing difficulties. EpiPen® is intended for injection of adrenaline into a muscle, and patients can administer the injection themselves, for example to manage their sensitivity to insect stings.

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