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Class II: temporary or reversible health riskTerminated

Threshold Enterprises Planetary Herbals Mullein Lung Complex Recall

Planetary Herbals Mullein Lung Complex

Threshold Enterprises Ltd · Scotts Valley, CA

Risk level
Class II
Reported by FDA
Mar 6, 2019
Recall ID
F-1097-2019
Check your lot numberHow we source this data

Summary

Threshold Enterprises recalled Planetary Herbals Mullein Lung Complex starting Dec 7, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report F-1097-2019 on Mar 6, 2019. Reason: Recall of Mullein Lung Complex due to a labeling error which indicates the incorrect excipient profile (inactive ingredients). Status: Terminated.

Why it was recalled

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

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide distribution

What to do if you have this product

  • Compare the brand, size, and lot/UPC codes on your package with the codes above.
  • If it matches, don't eat it. Return it to the store for a refund or throw it away.
  • Wash surfaces and containers that touched the product.
  • If you feel sick after eating it, contact your doctor. In an emergency call 911.

Recall details

Recall number
F-1097-2019
Classification
Class II
Status
Terminated
Recall initiated
Dec 7, 2018
FDA report date
Mar 6, 2019
Quantity
16, 542 units
Recall type
Voluntary: Firm initiated
Recalling firm
Threshold Enterprises Ltd

Original FDA data

Every field from FDA enforcement report F-1097-2019, exactly as published.

Show all FDA fields
City
Scotts Valley
State
CA
Status
Terminated
Country
United States
Event ID
82088
Address
23 Janis Way
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
Postal code
95066-3506
Report date
Mar 6, 2019
Product type
Food
Recall number
F-1097-2019
Classification
Class II
Recalling firm
Threshold Enterprises Ltd
Product quantity
16, 542 units
Termination date
Jun 7, 2019
Reason for recall
Recall of Mullein Lung Complex due to a labeling error which indicates the incorrect excipient profile (inactive ingredients).
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide distribution
Recall initiation date
Dec 7, 2018
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date
Feb 26, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report F-1097-2019, published Mar 6, 2019. View the source record (openFDA) · FDA enforcement reports

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

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