NDAL MFG INC Issues Voluntary Nationwide Recall of ManukaGuard Allercleanse Nasal Spray Due to Contamination with Yeast - 2/12/21
Company Announcement Date:
February 10, 2021
FDA Publish Date:
February 10, 2021
Reason for Announcement:
Due to Yeast Contamination
NDAL MFG INC
Allercleanse Nasal Spray
NDAL MFG INC is voluntarily recalling one lot of Manukaguard Allercleanse, nasal spray to the consumer level. The Allercleanse nasal sprays have been found to be contaminated with yeast.
Risk Statement: The use of Allercleanse (manuka honey) nasal spray contaminated with yeasts, in the population most likely to use it (children, adults, and elderly), may result in adverse events that necessitate medical or surgical intervention. However, use of this contaminated product in immunosuppressed individuals may result in life threatening invasive fungal infections. NDAL MFG INC has not received any reports of adverse events related to this recall.
The product is used as a NASAL SPRAY to clean nasal passages and sinuses of irritants and other environmental contaminants and is packaged in cardboard box with one nasal spray per box UPC 858631002128. The affected Allercleanse lot is lot # 2010045 and BB 10/2023 expiration date. Product was distributed Nationwide in the USA to 1 e-commerce website amazon.com, distributors and retail stores.
NDAL MFG INC has notified its distributors and customers by e-mail followed by telephone and further email and has arranged for return/replacement etc. of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using/return to place of purchase/discard/contact their doctor, etc., if they have not already done so.
Consumers with questions regarding this recall can contact NDAL MFG INC by phone 1-800-916-1220 or e-mail address SUPPORT@MANUKAGUARD.COM, M-F 7:30 am to 4 pm PST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
* We believe that none of the product being recalled were processed or offered through the national office
* We strongly encourage you to notify your agencies within one business day from receipt of this notice.
* ALL cased and uncased inventories, both at the member level and agency level, need to be checked. This product may have entered member and agency warehouses through salvage, local donations, TEFAP, local purchases, retail pickups, food drives, or other avenues.
* For additional local details, please contact the Health Department(s) for the area(s) your food bank serves.
About Feeding America Recall Notices
The Feeding America national office issues notifications of all national Class I and II recalls–those involving a health hazard situation in which there is reasonable probability that eating the food will cause health problems or death–and other recalls that may affect the safety of food supplied to network members.
The national office strongly encourages all member product solicitors, operations managers, and others involved in food and grocery distribution to regularly consult resources provided by the United States Food and Drug Administration (FDA) at http://www.fda.gov/opacom/7alerts.html, and the United States Department of Agriculture (USDA) at http://www.fsis.usda.gov/Fsis_Recalls/index.asp. Additionally, members can often receive information on national, state, and local recalls by contacting their local health departments.
Feeding America National Office
35 E. Wacker Drive, Suite 2000
Chicago, IL 60601