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State officials have issued an urgent alert to administrators of naloxone after Teleflex Medical issued a nationwide product recall on the MAD300 nasal atomizer. The recall does not impact the medication itself, but rather a part of the device used to administer the drug. The recall was issued after it was discovered that faulty nasal atomizers shoot a stream of naloxone into patients’ noses rather than producing a mist, potentially making the overdose reversal drug less effective.

Additional items manufactured by Teleflex Medical also subject to recall include a number of syringe/atomizers combinations, due to the same concern that the recalled devices will not appropriately create the mist required for proper absorption of medications. To see the full recall list issued by Teleflex Medical, click here

Officials are urging health departments, first responders, pharmacies, nonprofits and any individuals with access to naloxone to immediately check their supplies and take the necessary steps to replace any atomizers impacted by the recall. Medication should not be discarded. Additionally, nasal atomizers not subject to this recall may still be used to administer naloxone in the event of an overdose.  To read full release, click here.

 

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Atomizer Package   Lot Number DAWN

 

The following lot numbers are listed in the product recall:

 

160108                160231                     160440                                160708

          160117                160300                     160500                                160718          

160126                160313                     160518                                160728

160145                160327                     160602                                160800

160146                160400                     160611                                160804

160200                160409                     160621                                160814

160219                160422                     160631                                160816

160225                160432                     160701                                160823

 

 

Frequently Asked Questions

What is the Nasal Atomizer?

  • The nasal atomizer screws onto the end of your naloxone syringe and turns the medication into a mist as it is dispensed into the nose of a person who appears to have overdosed. It is contained in a separate plastic wrapper from the syringe.

 

How is the atomizer defective?

  • The atomizer may deliver a straight stream of medication rather than a spray of medication as intended.

 

Is it just the MAD 300 nasal atomizer that is subject to recall?

  • No, additional products of a similar nature are also recalled.  Please see the Teleflex Medical recall notice, linked here, for the full list of recalled Teleflex products.  The MAD 300 is the only item stocked by the Ohio Pharmacy Service Center and included in the Project DAWN kits as distributed by the Ohio Pharmacy Service Center.

 

Do I need to open the atomizer to verify if it is impacted?

  • No, you should be able to see the lot number on the outside of the atomizer packaging without having to open the package. You will need to open the Project DAWN kit and extract the atomizer in their plastic packaging.

 

Where can I find the lot number?

  • Please open your Project DAWN kit and spread the materials out in front of you. The atomizer is a small object that screws onto the end of the tube of naloxone. There should be two of them in your Project DAWN kit, both in separate small white plastic packages that should have the words “MAD Nasal” in large print. Please locate the Lot number in the bottom right hand corner of the package and compare to the list of recalled lots.

 

My Project DAWN kit nasal atomizer is part of the recall – now what?

  • Contact the location where you purchased or received the kit. If you purchased the kit through the Ohio Pharmacy Services, please contact Ohio Pharmacy Services at 614-752-0134 about how to obtain replacement kits. If you purchased directly from a pharmacy, please contact that pharmacy for information on how they handle product recalls. If you obtained the kit from a Project DAWN, please contact the Project DAWN for a replacement.

 

Should I throw away my Project DAWN kit once I determine the atomizers are recalled?

  • No, please do not throw away the Project DAWN kit.  Once new atomizers are available your kit can be restored to full functionality.  The naloxone itself is still good and not subject to recall.

 

 

 

Last Updated: 11/6/2016