ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray…

Date

March 3, 2021

Risk class

Class I (FDA's definition, 21 CFR 7.3(m): 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)

Status

Ongoing

Filed by

NDAL Mfg Inc.

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 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)

Reason

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

Distribution pattern

Distributed Nationwide in the USA and Hong Kong

Quantity

4265 bottles

Codes and lots

LOT # 2010045; Best Before 10 2023

Recall started

Dec. 17, 2020

Recall number

D-0269-2021

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-0269-2021. The agency record governs; check it and the company before acting.