Multi-event February 2019 FDA Recall Drug by Mcdaniel Life-line Llc

This Multi-event Class II drug recall was voluntarily initiated by Mcdaniel Life-line Llc on February 8, 2019 for the product Drug. The FDA reported the reason for recall as unapproved new drug. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1112-2019 TERMINATED D-1111-2019 TERMINATED

Recall Number: D-1112-2019

Reason for Recall
Unapproved new drug
Initiated
02-08-2019
Reported
04-17-2019
Quantity
Unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82106
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
McDaniel Life-Line LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide, Italy, Australia, Canada, Poland
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-15-2020
Product Description About Product Description
Full technical description of the product.
Life-Line tm Catalytic Activated Energy Water, 1 gallon container, McDaniel Life-Line LLC 1775 US Hwy 385 806-647-1741 Dimmitt, TX 79027

Batch or Lot Expiration Information

Lot# All lots within expiry.

Recall Number: D-1111-2019

Reason for Recall
Unapproved new drug
Initiated
02-08-2019
Reported
04-17-2019
Quantity
150 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82106
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
McDaniel Life-Line LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide, Italy, Australia, Canada, Poland
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-15-2020
Product Description About Product Description
Full technical description of the product.
Indian Herb Paste (a dietary supplement) Ingredients: Galangal, Indian Paint, Yellow Dock & Licorice in an alloy of Life-Line tm and Zinc Chloride in 6 dram vials, McDaniel Life-Line LLC, Dimmitt, TX

Batch or Lot Expiration Information

Lot# All lots within expiry