Drug 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
D-1049-2020
Product summary
- Event
- Event 85072
- Status
- Terminated
- Classification
- Class III
- Quantity
- 659 bottles
- Official record key
drug-enforcement:D-1049-2020
Official wording
Reason: Labeling mix-up - Indications on product label are incorrect.
Code information: Lot # Z56673
Distribution pattern: U.S.A. Nationwide, Israel
Derived failure modes
-
Labeling or packaging
Labeling mix-up