Tag Archives: Epi-Pen Junior

FDA: Make Sure Epi-Pens Don’t Get Stuck in Tube

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According to manufacturer Pfizer Inc. and distributor Mylan, due to a defective label, a small number of EpiPen 0.3 mg and EpiPen Jr 0.15 mg auto-injectors and their authorized generics do not slide out of the tube easily. There are no issues with the device or the epinephrine inside.

People with an EpiPen should check to make sure it is not stuck in the carrier tube, according to a new warning from the manufacturer and federal health officials.

“It is vital for lifesaving products to work as designed in an emergency situation, and patients and caregivers should inspect their epinephrine auto-injector prior to needing it to ensure they can quickly access the product,” the Food and Drug Administration said in a safety alert.

Anyone with an auto-injector that does not easily slide out or one that has a label that only is partially adhered to the auto-injector should contact MylanCustomer Relations at 800-796-9526.

 

http://www.aappublications.org/news/2018/11/07/epipens110718

Great News for Patients-Extended Expiration Dates for Select Lots of EpiPen 0.3 mg Auto-Injectors

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On Aug. 21, 2018, the U.S. Food and Drug Administration announced to extend the expiration dates of specific lots of EpiPen 0.3 mg Auto-Injectors and its authorized generic version. Patients should have confidence in using the products from these particular lots as Pfizer works to stabilize supply, which is anticipated in the fourth quarter of 2018.

Pfizer and Mylan’s recommendation to extend the expiration dates of specific lots, and the FDA’s decision were based on a careful review of data provided by Pfizer. We believe the extension of the expiration date will temporarily address patients’ access to and use of EpiPen 0.3 mg Auto-Injectors, and its authorized generic, particularly during back-to-school season as demand increases.

The affected lots, which have current expiration dates between April 2018 and December 2018, are listed in tables in the expandable sections below and can also be found on FDA’s website. The extension of the expiration dates does not apply to EpiPen Jr (epinephrine injection, USP) 0.15 mg Auto-Injectors and its authorized generic version. Patients should continue to adhere to the manufacturer’s expiry date labeled on EpiPen Jr 0.15 mg and Epinephrine Injection, USP Auto-Injectors 0.15 products.

https://www.epipen.com/en/about-epipen-and-generic/supply-information