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.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
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