ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray, 1.3 FL OZ (40mL) bottle, 270 mea...

FDA Recall #D-0269-2021 — Class I — December 17, 2020

Recall #D-0269-2021 Date: December 17, 2020 Classification: Class I Status: Ongoing

Product Description

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 for Recall

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

Recalling Firm

NDAL Mfg Inc. — Monterey, CA

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

4265 bottles

Distribution

Distributed Nationwide in the USA and Hong Kong

Code Information

LOT # 2010045; Best Before 10 2023

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated