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Threshold Enterprises Ltd Recall: Recall of Mullein Lung Complex due to a labeling error which indicates the incorrect excipient profile (inactive ingredients). - F-1097-2019

United States

TerminatedClass II

Company
Threshold Enterprises Ltd
Product
Planetary Herbals Mullein Lung Complex; 1000 mg; 15 count,…
Recall date
December 7, 2018
Terminated
June 7, 2019
Source
FDA

Reason for recall

Recall of Mullein Lung Complex due to a labeling error which indicates the incorrect excipient profile (inactive ingredients).

  1. - Recall initiated
  2. - Reported by source
  3. - Recall terminated
Recalled products
Product description UPC Quantity Lot / code information
Planetary Herbals Mullein Lung Complex; 1000 mg; 15 count, item number PF0003; 90 count - Item number PF0002; 180 count, Item number PF0106 and 90 + 90 count, PF 7013 white plastic bottles. Proprietary Blend: Platycodon root, Ophiopagon Rhizome, Long Pepper Fruit, Black Cherry Bark, Cassia Bark, Elecampane Root, Mullein Leaf, Licorice Root and Ginger Rhizome Extract. Manufactured for: Planetary Herbals LLC. P.O. Box 1760, Soquel, CA 95073 Not published in this source record 16, 542 units 15 count lot number and expiry dates: FG-85657 - 1/21 FG-90863 - 11/21 FG-94415 - 4/22 FG-96010 - 7/22 90 count: FG-84056 - 1/21 FG-90862 - 11/21 FG-94413 - 4/22 FG-96008 - 7/22 180 count: FG-84057 - 1/21 FG-87851 - 1/21 FG-90864 - 11/21 FG-94414 - 4/22 FG-96009 - 7/22 90 + 90 Count: FG-90865 - 11/21 FG-96011 - 7/22

Distribution

  • Nationwide distribution

Official source record

Agency
FDA
Dataset
FDA Food Enforcement (Recalls)
Recall number
F-1097-2019
Event ID
82088
Status
Terminated
Classification
Class II
Company
Threshold Enterprises Ltd
Product description
Planetary Herbals Mullein Lung Complex; 1000 mg; 15 count, item number PF0003; 90 count - Item number PF0002; 180 count, Item number PF0106 and 90 + 90 count, PF 7013 white plastic bottles. Proprietary Blend: Platycodon root, Ophiopagon Rhizome, Long Pepper Fruit, Black Cherry Bark, Cassia Bark, Elecampane Root, Mullein Leaf, Licorice Root and Ginger Rhizome Extract. Manufactured for: Planetary Herbals LLC. P.O. Box 1760, Soquel, CA 95073
Quantity
16, 542 units
Reason
Recall of Mullein Lung Complex due to a labeling error which indicates the incorrect excipient profile (inactive ingredients).
Recall initiation date
December 7, 2018
Report date
March 6, 2019
Classification date
Not published in this source record
Termination date
June 7, 2019
Distribution pattern
Nationwide distribution
UPC, lot, and code information
15 count lot number and expiry dates: FG-85657 - 1/21 FG-90863 - 11/21 FG-94415 - 4/22 FG-96010 - 7/22 90 count: FG-84056 - 1/21 FG-90862 - 11/21 FG-94413 - 4/22 FG-96008 - 7/22 180 count: FG-84057 - 1/21 FG-87851 - 1/21 FG-90864 - 11/21 FG-94414 - 4/22 FG-96009 - 7/22 90 + 90 Count: FG-90865 - 11/21 FG-96011 - 7/22
Voluntary or mandated
Voluntary: Firm initiated
Initial notification method
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Source last updated
Not tracked separately from the Public Health Trace retrieval date below
Public Health Trace retrieval date

Responsible company: Threshold Enterprises Ltd

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Distribution
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Product
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Published
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Distribution
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Where this information comes from

View FDA enforcement record -- the specific openFDA record this summary was built from.

This record comes from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information. See FDA Enforcement Reports versus recall announcements for how that database differs from a press-release-style announcement.

New to reading a recall record? See how to read an FDA recall record and what recall statuses mean.

Technical source data

View raw source data -- the machine-readable record this page's information was built from.

Retrieved by Public Health Trace:

Frequently asked questions

What does a Class II mean?

FDA classifies this recall as Class II. See how to read an FDA recall record (linked above) for what each classification level means.

Is this recall still active?

According to FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.

What should I do if I have this product?

Follow the responsible agency's published instructions, linked below -- recall guidance is set by that agency, not by Public Health Trace.

Official guidance and record verification

Public Health Trace does not provide medical advice -- review the linked official source below for current, authoritative information.

How to interpret this historical record

This record is preserved as published by FDA, as of June 7, 2019.

Status as reported: Terminated.

This page does not imply a current danger or a current consumer instruction -- review the official source for the most current information.

View the official FDA source

This summary is based on the official source record referenced above. Public Health Trace does not state that any company or product is unsafe beyond what the official source has published. Read the full medical disclaimer.

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