The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1111-2019·Announced 2019-04-17

McDaniel Life-Line Recalls Indian Herb Paste Due to Unapproved New Drug Status

McDaniel Life-Line LLC is voluntarily recalling 150 vials of Indian Herb Paste because the product is an unapproved new drug. The recall covers distribution in the US, Italy, Australia, Canada, and Poland.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states the agency classification is Class II. According to the severity rubric, an FDA Class II recall must be scored as 4 (Severe), regardless of whether specific injuries are reported in the text.

Plain-English summary

McDaniel Life-Line LLC is voluntarily recalling 150 vials of Indian Herb Paste. The product is a dietary supplement containing Galangal, Indian Paint, Yellow Dock, and Licorice in an alloy of Life-Line and Zinc Chloride, packaged in 6 dram vials. The recall was initiated on February 8, 2019, and was terminated on December 15, 2020.

The FDA classified this recall as Class II. The reason for the recall is that the product is an unapproved new drug. The affected units were distributed nationwide in the United States, as well as in Italy, Australia, Canada, and Poland. The recall includes all lots within their expiration dates.

Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions. The recall was initiated by the firm and notified via press release.

The recalled product

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
Manufacturer
McDaniel Life-Line LLC
Category
Drug — Dietary Supplement
Hazard
Affected units
150

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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