Naloxone Nasal Atomizer Recall (Item #MAD300)

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Contact: Greg Moore (419) 213-4245 November 4, 2016

***Officials at the Health Department will be available at 4:15PM to answer any questions***
Naloxone Nasal Atomizer Recall (Item #MAD300)

Ohio Pharmacy Service Center (OPSC) has received a product recall issued by Teleflex Medical, the makers of the MAD300 nasal atomizer used in the Project DAWN kits that are assembled at OPSC. The product recall was issued for 32 lot numbers of the MAD300 product. Teleflex has confirmed that the affected lot numbers were sold after January 1, 2016. Many Project DAWN kits distributed to date are not subject to this recall and have working atomizers. However, we are asking that you check the lot numbers on all atomizers purchased after January 1, 2016. A product exchange for kits obtained from Ohio Pharmacy Services will be made for those atomizers with affected lot numbers only.

For help in locating the atomizer lot number please see the attached examples. 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

The recall contains the following statement:
“Teleflex Medical is recalling these products as they may not deliver a fully atomized plume of medication. Teleflex Medical has received complaints that the affected lots produced a straight stream instead of an atomized spray. The failure of the device to deliver an atomized plume may impair the effectiveness of the medication with which it is used. This can lead to serious injury or death in certain emergency situations, such as where the device is used in an off-label manner for needle-free delivery of drugs for reversal of life threatening narcotic overdose, reversal of life threatening hypoglycemia, or treatment of epileptic seizures.”
This recall does not impact the medication itself, but rather the nasal atomizer, which is used to administer the drug. The recall was issued after it was discovered that faulty atomizers shoot a stream of naloxone into patients’ noses rather than producing a mist, potentially making the overdose reversal drug less effective.

At this time Teleflex Medical has not established a date when they will be releasing new product. Alternative forms of naloxone may be available, including Narcan NS™. This product contains two intranasal plunger devices that deliver
4mg of naloxone per dose. We encourage you to visit\stopoverdose to view the list of pharmacies that may have this product in stock. It is recommended that you call the pharmacy in advance to confirm availability.

Customers who have purchased Project Dawn Kits and or MAD300 atomizers should return them to the place of their “original” purchase. Toledo-Lucas County Health Department is asking for any kits purchased from their pharmacy with these lot numbers be returned for replacement on Tuesday, November 9, 2016.

Please check on Tuesday, November 9, 2016 for the times for replacement.

If you have any questions about this recall, please call the Ohio Department of Health’s toll-free hotline: 1-844-364-4063