Recalls / Class II
Class IIF-1097-2019
Product
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
- Type
- Food
- Affected lot / code info
- 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
- Quantity
- 16, 542 units
Why it was recalled
Recall of Mullein Lung Complex due to a labeling error which indicates the incorrect excipient profile (inactive ingredients).
Recalling firm
- Firm
- Threshold Enterprises Ltd
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 23 Janis Way, Scotts Valley, California 95066-3506
Distribution
- Distribution pattern
- Nationwide distribution
Timeline
- Recall initiated
- 2018-12-07
- FDA classified
- 2019-02-26
- Posted by FDA
- 2019-03-06
- Terminated
- 2019-06-07
- Status
- Terminated
Source: openFDA Food Enforcement endpoint. Recall record F-1097-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings.