Mylan SA and Meridian Medical Technologies, a Pfizer subsidiary, have issued an urgent recall of their EpiPen injector, which is used by patients who have allergies, saying there was a defect with the device, reports Business Day.
Used for anaphylaxis in patients, which is triggered by insect bites, or stings, and allergic reactions, the EpiPen auto injector comes in both junior and senior doses and retails at about R1,000 per device. In an emergency situation, it could be deadly for patients to not have properly functioning devices and they could suffer serious health consequences.
Mylan SA head of strategic projects Tanya Anhaeusser is quoted in the report as saying that the voluntary recall was a precautionary measure to safeguard patients after incidents in the US and Asia during which two devices were reported to be faulty and the needles were unable to inject the amount of fluid that was necessary. In both incidents, the company said, the contents of the devices were normal, but the actual devices were defective and there was a “potential default in the supplier component”, hence the recall on a worldwide scale.
Anhaeusser said the firm was conducting the recall because the South African stock had been part of the same batch in which the two faulty devices were found abroad, “but there has been no incidents or complaints made in SA so far”. The company has committed itself to replacing these devices at no additional cost to customers. Mylan SA identified the EpiPen 0.3mg/0.3ml auto injector with batch number 36388, of which the company had stocked 1,211 units, as part of the faulty batch. The EpiPen Junior injectors, of which the company had brought in about 500 units, with batch numbers 36093, 36178 and 36288, were also part of the global recall.
The report says according to Anhaeusser, three of the four product batches were now close to expiry in May 2017, so customers who wished to return their product would be getting a fresh set of medication and devices. These usually last for a year.
The company said it would be working with a medical courier to collect faulty products from customers and replace them with well dated, functioning stock. The company is working with the Medical Controls Council to help it carry out the recall of the devices.
It was announced earlier that more than 80,000 EpiPens are being recalled across multiple countries because they might fail to work in an emergency. According to a Stat News report, the devices included in the recall were distributed in Australia, New Zealand, Japan, and a variety of European countries, but not in the US.
In two cases, the EpiPens actually did not work, though the company did not specify whether anyone was injured as a result of the failure. A Mylan spokesperson said that the two individuals were able to use different EpiPens to relieve their symptoms.
EpiPens are auto-injectors that deliver lifesaving doses of epinephrine to individuals suffering from severe allergic reactions. When pressed into the thigh of a person experiencing anaphylactic shock, it triggers a needle to shoot through the person’s skin and deliver epinephrine directly into the muscle.
The report says that according to the company statement, recalled pens may contain a “defective part” that “may result in the device failing to activate or requiring increased force to activate”.
EpiPens are manufactured by Meridian Medical Technologies, a US-based subsidiary of Pfizer.
According to government agencies, nearly 500 EpiPens have been recalled in Denmark and about 2,000 in Norway, along with an unspecified number in Finland and Ireland. A Norwegian Medicines Agency news release notes that EpiPens covered under this recall had been for sale in Norway since January 2016.