SILVER SPRING, MD (KTAL/KMSS) — A company has issued a nationwide recall of its nasal spray because it may be contaminated with yeast.
According to the U.S. Food and Drug Administration, NDAL MFG INC is voluntarily recalling one lot of Manukaguard Allercleanse Manuka Honey.
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 events that necessitate medical or surgical intervention. However, use of this contaminated product in immunosuppressed individuals may result in life-threatening invasive fungal infections.
NDAL MFG INC has not received any reports of adverse events related to this recall.
The spray is used to clean nasal passages and sinuses of irritants and other environmental contaminants and is packaged in cardboard box with one nasal spray per box UPC 858631002128. The affected Allercleanse lot is lot # 2010045 and BB 10/2023 expiration date.
The nasal spray was distributed nationwide to amazon.com, distributors and retail stores.
If you have this nasal spray stop using it and return it to the store or throw it away.
If you have questions regarding this recall contact NDAL MFG INC by phone (800) 916-1220 or e-mail address SUPPORT@MANUKAGUARD.COM, M-F between 7:30 a.m. to 4 p.m. PST.
You should contact their doctor if you experience any problems that may be related to taking or using this nasal spray.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax:
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178