D-1049-2020 Class III Terminated
FDA drug recall D-1049-2020 was initiated by Grato Holdings, Inc. on November 15, 2019 and is designated Class III. Reason for recall: Labeling mix-up - Indications on product label are incorrect. The recall status is terminated (terminated September 28, 2020). Affected quantity: 659 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 1, 2020
- Initiation Date
- November 15, 2019
- Termination Date
- September 28, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 659 bottles
Product Description
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
Reason for Recall
Labeling mix-up - Indications on product label are incorrect.
Distribution Pattern
U.S.A. Nationwide, Israel
Code Information
Lot # Z56673