Why it was recalled
Labeling mix-up - Indications on product label are incorrect.
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
Lot numbers, UPCs & expiration codes
Lot # Z56673
Where it was sold
U.S.A. Nationwide, Israel
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1049-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 15, 2019
- FDA report date
- Apr 1, 2020
- Quantity
- 659 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Grato Holdings, Inc.
Original FDA data
Every field from FDA enforcement report D-1049-2020, exactly as published.
Show all FDA fields
- City
- Woodbine
- State
- IA
- Status
- Terminated
- Country
- United States
- Event ID
- 85072
- Address
- 201 Apple Blvd
- Code information
- Lot # Z56673
- Postal code
- 51579-1503
- Report date
- Apr 1, 2020
- Product type
- Drugs
- Recall number
- D-1049-2020
- Classification
- Class III
- Recalling firm
- Grato Holdings, Inc.
- Product quantity
- 659 bottles
- Termination date
- Sep 28, 2020
- Reason for recall
- Labeling mix-up - Indications on product label are incorrect.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- U.S.A. Nationwide, Israel
- Recall initiation date
- Nov 15, 2019
- Initial firm notification
- Letter
- Center classification date
- Mar 20, 2020