Manukaguard Allercleanse Nasal Spray Recall [US]


Manukaguard Allercleanse Nasal Spray Recall [US]

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US FlagUS/Silver Spring: Ndal Manufacturing Industries, Inc., a Monterey, California establishment, recalls certain batch/lots of Manukaguard Allercleanse Nasal Spray products from the American marketplace due to suspected Yeast contamination and consequential risks of infection, severe illness and/or possible life-changing complications, all serious health hazards.

FDA: http://ht.ly/awOM30rwSR6

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ndal-mfg-inc-issues-voluntary-nationwide-recall-manukaguard-allercleanse-nasal-spray-due

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Nasal Spray products are subject to this recall:

  • Manukaguard Allercleanse Nasal Spray, sold in 1.3 fluid ounce (40 ml) bottles with a batch/lot designation of 2010045 and an expiration date of 10/2023

Please consult the photograph above for details of the drug’s packaging, design and retail presentation.

==> No barcodes, UPCs, NDCs, DINs, item numbers, manufacturing date codes, production dates, expiry dates, regulatory approval designations, registration numbers, agency approval designations or other identification numbers were listed with this recall notification.

These Nasal Spray products were known to be marketed, distributed and sold in all US states through Amazon.com, traditional distributors and retail stores although it is always possible these drug products had wider distribution within outside the country. When in doubt, please contact the manufacturer for specific product information.

According to the FDA, the use of Allercleanse (Manuka Honey) Nasal Spray contaminated with Yeasts in the population most likely to use it (children, adults and elderly), may result in adverse health events that necessitate medical and/or surgical intervention. However, use of this contaminated product in immunosuppressed individuals may result in life threatening invasive fungal infections.

As a result of this reported defect, you should not use the recalled Nasal Spray products identified above.

==> For information about Yeast contamination, please consult the “Illnesses” tab on this site, located at the top of this page.

==> Never depend on your senses of sight, smell, taste or touch to confirm drug poisoning, adulteration or contamination. If in doubt about the safety of any drug, return it to your retailer for refund, making sure neither small children nor household pets can access the suspect product.

If you believe you have purchased or have in your possession any of the recalled Nasal Spray products, please do not use them directly. Instead, return the Nasal Spray products to the store where you purchased it for a full refund.

==> If you have a medical emergency, please contact 9-1-1, your closest hospital or emergency center equipped to properly treat Yeast contamination.

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US Centers for Disease Control and Prevention Coronavirus Tips___________________________________________________________

If you have any further questions, comments or complaints about this recall, please contact toll-free at 1-800-916-1220 from 7:30 AM to 4:00 PM Pacific Standard Time, Monday to Friday or by e-mail at support@manukaguard.com.

==> To see other recalls and notifications caused by suspected faulty and/or dangerous Allercleanse (Manuka Honey) Nasal Spray, please search for “nasal spray” or more generically, “drug” using the Search Box at the top of this page.

==> To see other recalls and notifications caused by suspected Yeast contamination, please search for “yeast” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by Ndal Manufacturing Industries, please search for “Ndal Manufacturing” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold under the Manukaguard Allercleanse brand, please search for “Manukaguard” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 14100-2021
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
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General information:
More recalls? Back to the main Recalls Direct page:
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Visit the Living Safely site:
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Search for a recalled food or drug on the US FDA Web archive [external: new window opens]:
==> http://www.fda.gov/Safety/Recalls/ArchiveRecalls/default.htm

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