Indian Herb Dietary Supplement Recall [US]


US FlagUS/Silver Spring: Indian Herb Dietary Supplement Recall [US]McDaniel Life-Line LLC, a Felt, Oklahoma establishment, recalls all current batch/lots of Indian Herb Dietary Supplements due to suspected failure to gain required regulatory NDA/ANDA approval and consequential risk temporary or permanent damage or loss of body function or structure, all serious health and safety hazards. To date, McDaniel Life-Line LLC has received a report of one (1) adverse injury.

FDA: http://ht.ly/5UUd30nE9Vr

Direct link: https://www.fda.gov/Safety/Recalls/ucm631039.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Dietary Supplement products are subject to this recall:

  • Indian Herb Dietary Supplements, ostensively containing Galangal, Indian Paint, Yellow Dock and Licorice in an alloy of Life-Line and Zinc Chloride and sold in 6 dram vials

Please consult the photograph above for details of the food’s packaging, design and retail presentation.

==> No barcodes, UPCs, DINs, item numbers or other identification numbers were listed with this recall notification.

According to the FDA, McDaniel Life-Line LLC has recalled all current batch/lots of its Indian Herb because it was marketed without an approved NDA/ANDA from the FDA. The therapeutic claims made in the labeling for this product establish that it is a Drug because it is an article (other than food) intended to affect the structure or any function of the body. Additionally, the Indian Herb contains ingredients that the FDA has determined to be Caustic in nature that can cause serious injury.

If you believe you have purchased or have in your possession any of the recalled Indian Herb, please do not consume them directly nor use them as an ingredient in another dish or preparation. Instead, return the drug to the store where you purchased it for a full refund or local pharmacy for proper disposal.

==> If you have a medical emergency, please contact 9-1-1, your closest hospital or emergency center equipped to handle poisonings.

==> To see other recalls and notifications caused by Burns, please search for “burn” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by McDaniel Life-Line, please search for “McDaniel Life-Line” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 11102-2019
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
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General information:
More recalls? Back to the main Recalls Direct page:
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Visit the Living Safely site:
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==> http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095859.htm
Search for a recalled food or drug on the US FDA Web archive [external: new window opens]:
==> http://www.fda.gov/Safety/Recalls/ArchiveRecalls/default.htm

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E. & O. E.

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