The Recall Desk
HighFDA (Drugs)·D-1112-2019·Announced 2019-04-17

FDA Recalls Life-Line Catalytic Activated Energy Water as Unapproved New Drug

McDaniel Life-Line LLC is voluntarily recalling Life-Line Catalytic Activated Energy Water because it is an unapproved new drug. The product was distributed in the US and several international countries.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The hazard is the use of an unapproved new drug, which fits the 'High' severity criteria for risk-of-harm products where specific injury reports are not detailed in the source text.

Plain-English summary

McDaniel Life-Line LLC is voluntarily recalling Life-Line Catalytic Activated Energy Water, 1 gallon containers, because the product is an unapproved new drug. The recall was initiated on February 8, 2019, and was classified as Class II by the FDA. The recall status is currently terminated.

The affected product was distributed nationwide in the United States, as well as in Italy, Australia, Canada, and Poland. The recall covers all lots within their expiration dates. The firm notified the public via a press release.

Consumers who have purchased this product should stop using it and contact the recalling firm for instructions on how to return the product or obtain a refund, as per standard recall procedures for unapproved drugs.

The recalled product

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
Manufacturer
McDaniel Life-Line LLC
Category
Drug — Unapproved New Drug
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots within expiry.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by McDaniel Life-Line LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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