FDA recall F-1097-2019

Threshold Enterprises Ltd · Class II · food

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

Reason for recall

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

Distribution

Nationwide distribution

Key facts

Status
Terminated
Initiation date
2018-12-07
Report date
2019-03-06
Termination date
2019-06-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Scotts Valley, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-1097-2019