EpiPens Are Being Recalled in U.S. Because of Potential Defect

If you or a loved one carries an EpiPen or EpiPen Jr. auto-injector for use in the case of a dangerous allergic reaction, check the device’s lot number. A subset of devices distributed between December 2015 and July 2016 have been voluntarily recalled in the United States after the manufacturer received two reports that EpiPens did not activate as intended.

The two problems were caused by a defective part that could potentially make the device difficult to activate in an emergency, the Food and Drug Administration reported on Friday. Both reports occurred outside the United States, and in both cases the EpiPen users were able to receive treatment from an alternative device.

The voluntary recall began in mid-March in Europe, Japan, Australia, and New Zealand, and has since expanded into North and South America and other parts of Asia. In the U.S., 13 separate lots—with expiration dates of April, May, September, and October 2017—are included in the recall.

People who have EpiPen or EpiPen Jr. devices can check the 2-pack cartons or the auto-injectors themselves for lot numbers and expiration dates. The lots affected in the United States are 5GM631, 5GM640, 6GM082, 6GM072, 6GM081, 6GM088, 6GM199, 6GM091, 6GM198, and 6GM087 (regular EpiPen, 0.3 mg), and 5GN767, 5GN773, and 6GN215 (EpiPen Jr., 0.15 mg).

Any auto-injectors from those lots should be replaced as soon as possible, says a statement from Mylan, EpiPen’s distributor. But don’t toss them before you get your hands on a new one: “We are asking patients to keep their existing product until their replacement product can be secured,” says Mylan’s statement.

Instead, consumers are encouraged to visit mylan.com/EpiPenRecall or call 877-650-3494 for further instructions. Starting today, Mylan says, consumers will begin receiving vouchers to trade in for new replacement products at their local pharmacies. They’ll also receive a container for mailing back back the recalled devices.

As a replacement, consumers can receive either EpiPen branded auto-injectors or Mylan’s authorized generic equivalent. (None of the currently recalled lots include the generic version.)

RELATED: 31 Everyday Things That Can Trigger Allergies

If your EpiPen is from a lot not included in the recall, it does not need to be replaced before its expiration date, says Christina Ciaccio, MD, assistant professor of pediatrics at the University of Chicago Medical Center. However, she does recommend keeping an eye on the list of affected products, in case the recall expands further.

And for anyone who relies on EpiPen and is spooked by the news, Dr. Ciaccio offers some words of reassurance. “Recalls on epinephrine auto-injectors have occurred in the past,” she says, “but overall, the reliability of these devices has been excellent. Companies that manufacture auto-injectors have done an excellent job moving quickly when a problem has been discovered.”

That being said, she adds, it is always a good idea to carry more than one auto-injector—for two reasons. “The first is in case the auto-injector misfires, either by user error or manufacturing error,” she says. “The second is in case he or she needs a second injection before arriving at the emergency department.”

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According to Mylan’s statement, both of the reports that prompted the recall occurred in a single lot, and the defect that was responsible for the failures is extremely rare. However, the statement continues, the recall has being expanded to include additional lots “as a precautionary measure out of an abundance of caution.”

The EpiPen has been in the news consistently over the last few months, after a report in August showed that the device’s price had skyrocketed by more than 600% since 2008. To save money, some patients and doctors even resorted to making their own pre-filled epinephrine syringes.

In the past few months, several new commercial products have hit the market, as well: Mylan now produces its own generic auto-injector at a lower price; CVS announced its own generic version called Adrenaclick; and the competing brand Auvi-Q recently returned to the market—with new and improved safety checks—after it was voluntarily recalled in 2015.

Dr. Ciaccio says that she and her colleagues are “very excited” that several options of epinephrine auto-injectors are now available for patients to choose from. “If EpiPen is not the right device for you or you have difficulty getting one after the recall,” she says, “try another, or even carry more than one brand.”

EpiPens Are Being Recalled in U.S. Because of Potential Defect

Listeria, batteries and botulism: why food products get recalled

Fancy some blue chicken in your sandwich, or metal pieces in your ice cream? No, me neither. But those are some of the things that have caused food products to be recalled from shops since the beginning of 2016.

The Food Standards Agency (FSA) raises an alert when potentially harmful foods reach the marketplace in England, Wales and Northern Ireland. A total of 102 notices were posted between January 2016 and 29 March 2017.

More than a third of alerts are due to bacteria in food, including salmonella, E coli and listeria, which are often found in chicken and cheese. In February 2016 three supermarkets – Sainsbury’s, the Co-op and Asda – recalled Camembert cheese owing to concerns about the possible presence of listeria.

Nine recalls have been issued after salmonella was found in vegetable products including stir-fry mixes, spinach, guacamole, cumin powder and sesame seeds.

Following the discovery of faeces in empty cans at a Coca-Cola bottling plant in Northern Ireland this week, it’s worth noting that recalls prompted by suspicions of tampering are rare. Two have been issued in the past 15 months, when small batteries were found in hollow milk-chocolate Santas and Bunnies at the Co-op supermarket.

food recalls data graphic

Listeria, batteries and botulism: why food products get recalled

Residence-birthing pools recalled following infant falls sick with legionnaires" condition

PHE stated most birthing pools utilized at home, like this one, had been filled from domestic scorching-water techniques and so carry much less threat. Photograph: Mary Gascho/Getty

Hired home-birthing pools across the country have been recalled and hire companies place underneath scrutiny soon after a little one born using one particular of the heated pools created legionnaires’ condition.

The NHS and Public Health England (PHE) have banned specified varieties of house-birthing pools till further notice, soon after the child – who remains in hospital with severe pneumonia – became unwell.

Heated pools from the supplier have been recalled, with at least 6 other companies – employing out 60-70 pools – being questioned by PHE on their safety precautions. PHE explained it was “unclear” whether or not or not the organizations had carried out legionella danger assessments.

PHE said the tips was a “temporary” measure, and referred to the residence use of birthing pools with created-in heaters and recirculation pumps, which can be filled up to two weeks in advance of the birth. NHS England issued a patient safety alert on 17 June to alert midwives to the feasible risks associated with the use of this type of heated birthing pools at residence.

This is the very first reported situation of legionnaires’ ailment linked to a birthing pool in England, despite the fact that there have been two cases reported internationally in the late 1990s. Legionnaires’ disease, induced when the legionella bacteria is inhaled from contaminated water droplets, is incredibly rare in childhood, with only one particular situation in kids up to the age of nine reported in England among 1990 and 2011.

The PHE advised that the majority of birthing pools employed at house are filled from domestic scorching-water programs at the time of labour, which carry much less danger as long as pumps do not recirculate warm water. The recalled pumps have been delivered two weeks ahead of labour and, when filled from the tap, had been stored warm by a pump and heater until finally labour and delivery.

Prof Nick Phin, PHE’s head of legionnaires’ ailment, said: “Additional investigation into this incident has confirmed that the kind of legionella bacteria located in the birthing pool is the very same strain which triggered the child to turn into sick with legionnaires’ condition. As portion of the investigation, PHE has been functioning with neighborhood authorities to investigate the provision of these pools by a amount of firms, such as the advice given by the companies on pool filling and on controlling hazards from exposure to legionella.”

The decision to ban the birthing pools was based mostly on the trouble of preventing the growth of legionella in recirculated warm water over days or weeks in houses, he extra. “For this cause, PHE has confirmed its earlier precautionary tips and is recommending that this type of pre-filled, heated birthing pool is no longer used at all at property.”

Louise Silverton, director for midwifery at the Royal College of Midwives, mentioned that women should not be concerned if they were organizing a birth at residence making use of a conventional pool filled when they were in labour or making use of a fixed pool in an NHS unit. “Birthing pools in hospitals are topic to stringent infection-management procedures and monitoring,” she stated. “House-birthing pools filled for the duration of labour come with disposable liners and are only in area for a fairly brief time time period, minimizing possibility for bacterial growth. Any ladies with concerns about using home-birthing pools ought to make contact with their midwife or neighborhood maternity unit.”

Residence-birthing pools recalled following infant falls sick with legionnaires" condition