Recalls / Class III
Class IIID-1049-2020
Product
Colostat, Homeopathic Remedy, 1 fl. oz. (30 mL) per bottle, 20% Ethanol, Dist. by Energique, Inc., 201 Apple Blvd., Woodbine, IA 51579, NDC 44911-0411-1
- Brand name
- Colostat
- Generic name
- Rhamnus Purshiana, Spigelia Anthelmia, Taraxacum Officinale, Cajuputum, Hydrastis Canadensis, Alumina, Cina, Cinchona Officinalis, Lycopodium Clavatum, Magnesia Phosphorica, Mandragora Officinarum, Nux Vomica
- Active ingredients
- Aluminum Oxide, Artemisia Cina Pre-flowering Top, Cajuput Oil, Cinchona Officinalis Bark, Frangula Purshiana Bark, Goldenseal, Lycopodium Clavatum Spore, Magnesium Phosphate, Dibasic Trihydrate, Mandragora Officinarum Root, Spigelia Anthelmia Whole, Strychnos Nux-vomica Seed, Taraxacum Officinale
- Route
- Oral
- NDC
- 44911-0411
- Affected lot / code info
- Lot # Z56673
Why it was recalled
Labeling mix-up - Indications on product label are incorrect.
Recalling firm
- Firm
- Grato Holdings, Inc.
- Manufacturer
- Energique, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 201 Apple Blvd, N/A, Woodbine, Iowa 51579-1503
Distribution
- Quantity
- 659 bottles
- Distribution pattern
- U.S.A. Nationwide, Israel
Timeline
- Recall initiated
- 2019-11-15
- FDA classified
- 2020-03-20
- Posted by FDA
- 2020-04-01
- Terminated
- 2020-09-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1049-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.