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Mylan Provides Update on Meridian Medical Technologies’, a Pfizer Company, Expanded Voluntary Worldwide Recall of EpiPen®Auto-Injector

Return and Replacement Update(as of April 1, 5:45PM ET)

If you think you may be impacted by this recall, it is very important that you first contact Stericycle at 877-650-3494. Stericycle’s hours of operation are Monday-Friday 8 a.m.-10 p.m. ET, and Saturday and Sunday 8 a.m.-5 p.m. ET.

  • Stericycle will ask you questions about your EpiPen 2-Pak® or EpiPen Jr 2-Pak® cartons to confirm if the devices come from one of the recalled lots.
  • Prior to calling Stericycle, you can confirm if you are in possession of a recalled EpiPen product by checking if the lot number matches any of the lot numbers listed in the table below. If so, you need to contact Stericycle at 877-650-3494. If not, your EpiPen product is not affected by the recall and there is no further action necessary.
  • If you are in possession of a recalled EpiPen product, Stericycle will initiate the process of providing a container to return the recalled medication.
  • Stericycle also will collect your contact information and will begin contacting patients back on Monday, April 3, with voucher information to redeem a free replacement product.
  • Patients should not return any devices affected by the recall until they have received their voucher to redeem their free replacement from their pharmacy. It is important that patients continue to carry their current EpiPen Auto-Injector until they receive a replacement device.

Patients may receive either EpiPen Auto-Injector or Mylan’s authorized generic for EpiPen Auto-Injector at the pharmacy as a replacement based on availability. The authorized generic has the exact same drug formulation, has the exact same operating instructions and is therapeutically equivalent to EpiPen Auto-Injector, and may be substituted for EpiPen Auto-Injector.

Mylan is committed to replacing recalled devices at no cost and Mylan would like to reassure patients that there will be no additional replacement-related financial burden to them as a result of this recall.

Please check back here for any updates and additional information on the product return and replacement process.

Recall Details

Meridian Medical Technologies, a Pfizer company and Mylan’s manufacturing partner for EpiPen®Auto-Injector, has expanded a voluntary recall of select lots of EpiPen (epinephrine injection, USP) and EpiPen Jr® (epinephrine injection, USP) Auto-Injectors to now include additional lots distributed in the U.S. and other markets in consultation with the U.S. Food and Drug Administration (FDA).

The recall impacts certain lots of the 0.3 mg and 0.15 mg strengths of EpiPen Auto-Injector. None of the recalled lots include the authorized generic for EpiPen Auto-Injector, which is also manufactured by Meridian Medical Technologies.

The lot number is located on both the 2-Pak carton and the auto-injector. If the recalled EpiPen® Auto-Injector is still contained in the carton, refer to the left flap on the carton, which is black in color. You will find the lot number written in white and preceded by the word ‘LOT.’

On the auto-injector itself, you will find the lot number towards the top of the label in black and preceded by the word ‘LOT.’

NOTE: The NDC on the box ends with “2” because it contains two EpiPen Auto-injectors. The NDC on the individual EpiPen within the box has an NDC ending in “1.”

Additional Information

For additional information, please see the press release.

Patient and Customer Contact

To return your product, please contact Stericycle at 877-650-3494. If you have any additional questions regarding this recall, please contact Mylan Customer Relations at 800-796-9526 or customer.service@mylan.com.

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Please contact me with any questions or concerns.

ERosenberg@epps.org

or

201-796-8700 ext: #2993