NDAL Recalls ManukaGuard Nasal Spray Due to Yeast Contamination
NDAL Mfg Inc. is recalling ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray because the product was confirmed to contain yeast.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly identifies this as an FDA Class I recall, which mandates a severity score of 5 according to the rubric.
Plain-English summary
NDAL Mfg Inc. is recalling ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray, 1.3 FL OZ (40mL) bottles. The recall involves 4,265 bottles with Lot # 2010045 and a Best Before date of 10 2023. The product was distributed nationwide in the USA and in Hong Kong.
The recall was initiated because the product was confirmed to have yeast contamination. This is a Class I recall issued by the U.S. Food and Drug Administration.
Consumers should stop using the product and return it to the place of purchase or contact the recalling firm for instructions.
The recalled product
- Product
- ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray, 1.3 FL OZ (40mL) bottle, 270 measured sprays, Distributed by Ndal Laboratories, 449 Alvarado St., Monterey, CA 93940 (bottle); NDAL MFG Inc., 80 Garden Court, Suite 100, Monterey, CA 93940 (carton); UPC 8 58631…
- Manufacturer
- NDAL Mfg Inc.
- Category
- Drug — Nasal Spray
- Affected units
- 4,265
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- LOT # 2010045
- Best Before 10 2023
Distribution
Distributed nationwide across the United States.
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