Multi-event September 2020 FDA Recall Drug by Wishgarden Herbs, Incorporated

This Multi-event Class I drug recall was voluntarily initiated by Wishgarden Herbs, Incorporated on September 25, 2020 for the product Drug. The FDA reported the reason for recall as microbial contamination of a non-sterile product. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0220-2021 TERMINATED D-0218-2021 TERMINATED D-0219-2021 TERMINATED

Recall Number: D-0220-2021

Reason for Recall
Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
Initiated
09-25-2020
Reported
01-06-2021
Quantity
298 jars

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86709
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Wishgarden Herbs, Incorporated
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA, Egypt and Canada.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-29-2024
Product Description About Product Description
Full technical description of the product.
Goldenseal POWDER, 0.25 oz. (7 g) plastic jars, WishGarden Herbs, Inc., Boulder, CO 80301. UPC 6 56490 64137 9

Batch or Lot Expiration Information

Lot# P116 - Exp. 12/2020; P117 - Exp. 05/2021; P118 - Exp. 10/2021; P119 - Exp. 01/2022; P120 - Exp. 04/2022

Recall Number: D-0218-2021

Reason for Recall
Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
Initiated
09-25-2020
Reported
01-06-2021
Quantity
46 jars

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86709
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Wishgarden Herbs, Incorporated
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA, Egypt and Canada.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-29-2024
Product Description About Product Description
Full technical description of the product.
Happy Ducts Compress, 3 oz. plastic jar, www.wishgardenherbs.com, Boulder, CO. 80301. UPC 6 56490 20223 5

Batch or Lot Expiration Information

Lot# 53664, Exp 08/2022

Recall Number: D-0219-2021

Reason for Recall
Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
Initiated
09-25-2020
Reported
01-06-2021
Quantity
1651 jars

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86709
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Wishgarden Herbs, Incorporated
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA, Egypt and Canada.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-29-2024
Product Description About Product Description
Full technical description of the product.
Cord Care POWDER, 0.25 oz. (7 g) plastic jars, Wishgarden Herbs, Inc., Boulder, CO 80301. UPC 6-56490 24730 4

Batch or Lot Expiration Information

Lot# : P227 - Exp. 11/2020; P228 - Exp. 12/2020; P229 - Exp. 02/2021; P230 - Exp. 04/2021; P231 - Exp. 06/2021; P232 - Exp. 09/2021; P233 - Exp. 01/2022; P234 - Exp. 05/2022; P235 - Exp. 08/2022