NDAL MFG Inc. called back one lot of Manukaguard Allercleanse nasal spray citing yeast contamination, the U.S. Food and Drug Administration said in a statement.
The spray is used to clean nasal passages and sinuses of irritants and other environmental contaminants.
The recalled Allercleanse lot is lot # 2010045, with expiration date of BB 10/2023.
According to the agency, the use of Allercleanse (manuka honey) nasal spray contaminated with yeasts may cause adverse effect on children, adults, and elderly, who are mostly likely to use it. And use of this by individuals who are immunosuppressed could result in life threatening invasive fungal infections.
However, so far, NDAL MFG has not received any adverse reports.
The product was distributed nationwide to e-commerce website amazon.com, distributors and retail stores. It is packaged in cardboard box with one nasal spray per box with UPC code 858631002128.
NDAL MFG urged consumers to stop using the product and return them to the place of purchase or discard them. Consumers are also advised to contact their doctor if they experience any problems that may be related to taking or using this nasal spray.
In a similar product recall in August 2020, Ferring Pharmaceuticals US had recalled various nasal sprays citing superpotency or amounts of desmopressin higher than specified.
The recall involved all lots on the market of DDAVP Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, and STIMATE Nasal Spray 1.5 mg/ml.
The risks associated with higher than specified amounts of desmopressin relate to abnormally low levels of sodium in the blood, i.e., hyponatremia, which could eventually lead to seizure, coma, and death.
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