Terminated Class II

Threshold Enterprises Ltd

Recall F-1097-2019 · Scotts Valley, CA

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

Quantity affected

16, 542 units

Recall type

Voluntary: Firm initiated

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

Timeline

7 Dec 2018 initiated 26 Feb 2019 classified 6 Mar 2019 reported 7 Jun 2019 terminated

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