ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray recalled over sterility concerns

Recall date

December 17, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

NDAL Mfg Inc. recalls ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray, 1.3 FL OZ (40mL) bottle, 270 measured sprays, Distribu…

Recall number

D-0269-2021

FDA classification

Class I

Brand / firm

NDAL Mfg Inc.

Sold / distributed

Distributed Nationwide in the USA and Hong Kong

Why it was recalled

Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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 00212 8. the Alvarado St. is for the bottle by putting "(bottle); NDAL MFG Inc., 80 Garden Court, Suite 100, Monterey, CA 93940 (carton); UPC 8 58631 00212 8." (according to the label)