Danish pharmaceutical company Novo Nordisk A/S is recalling 1,468 product samples of Levemir, Tresiba, Fiasp, Novolog and Xultophy to the consumer level, due to improper storage temperature conditions, the U.S. Food and Drug Administration said.
The recall only impacts product samples and does not impact product that has been broadly distributed to pharmacies or mail-order services. The affected product can be identified by looking for the batch number or lot number located on the product or carton.
These products are used to lower blood glucose levels in people with diabetes and are packaged in cartons with either a vial, pen-injector, such as FlexPen or FlexTouch, or a cartridge – PenFill.
According to the agency, if product samples are exposed to temperatures below 32°F, it could cause a lack of efficacy and damage to the cartridge and pen-injectors. The use of improperly stored vial, cartridge or pen-injector could cause a risk that the user might not receive the right amount of medicine as intended which may lead to hyperglycemia or hypoglycemia resulting in adverse health consequences ranging from limited to life-threatening.
However, Novo Nordisk has not received any reports of serious adverse events or injuries related to this recall to date.
The company said it has notified all physician offices that received affected samples and requested to return all impacted samples.
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