December 2020 FDA Recall Drug by Ndal Mfg Inc.
D-0269-2021 - Microbial Contamination of Non-Sterile Products

This Class I drug recall was voluntarily initiated by Ndal Mfg Inc. on December 17, 2020 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0269-2021

Reason for Recall
Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast
Initiated
12-17-2020
Reported
03-03-2021
Quantity
4265 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87101
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is 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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
NDAL Mfg Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA and Hong Kong
Product Description About Product Description
Full technical description of the 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)

Batch or Lot Expiration Information

Lot# 2010045; Best Before 10 2023