FDA recall D-0269-2021

NDAL Mfg Inc. · Class I · drug

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 for recall

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

Distribution

Distributed Nationwide in the USA and Hong Kong

Key facts

Status
Ongoing
Initiation date
2020-12-17
Report date
2021-03-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Monterey, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0269-2021