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Class II: temporary or reversible health riskTerminated

McDaniel Life-Line Indian Herb Paste Recall

Indian Herb Paste (a dietary supplement) Ingredients: Galangal, Indian Paint, Yellow Do…

McDaniel Life-Line LLC · Felt, OK

Risk level
Class II
Reported by FDA
Apr 17, 2019
Recall ID
D-1111-2019
Check your lot numberHow we source this data

Summary

McDaniel Life-Line recalled Indian Herb Paste starting Feb 8, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1111-2019 on Apr 17, 2019. Reason: Unapproved new drug. Status: Terminated.

Why it was recalled

Unapproved new drug

Product description

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

Lot numbers, UPCs & expiration codes

All lots within expiry

Where it was sold

Nationwide, Italy, Australia, Canada, Poland

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1111-2019
Classification
Class II
Status
Terminated
Recall initiated
Feb 8, 2019
FDA report date
Apr 17, 2019
Quantity
150 vials
Recall type
Voluntary: Firm initiated
Recalling firm
McDaniel Life-Line LLC

Original FDA data

Every field from FDA enforcement report D-1111-2019, exactly as published.

Show all FDA fields
City
Felt
State
OK
Status
Terminated
Country
United States
Event ID
82106
Address
Hc 1 Box 2b
Code information
All lots within expiry
Postal code
73937-9703
Report date
Apr 17, 2019
Product type
Drugs
Recall number
D-1111-2019
Classification
Class II
Recalling firm
McDaniel Life-Line LLC
Product quantity
150 vials
Termination date
Dec 15, 2020
Reason for recall
Unapproved new drug
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
Nationwide, Italy, Australia, Canada, Poland
Recall initiation date
Feb 8, 2019
Initial firm notification
Press Release
Center classification date
Apr 9, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1111-2019, published Apr 17, 2019. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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