Why it was recalled
cGMP violations
Product description
Yeast Arrest, Homeopathic Formula, Vaginal Support suppositories, packaged in a) 14-count carton (NDC 68093-0730-1 and 68093-0730-3), b) 28-count carton (NDC 68093-0730-2 and 68093-0730-4), Manufactured for: Vitanica, 12401 SW Leveton Drive, Tualatin, OR 97062.
Lot numbers, UPCs & expiration codes
Lot #: a) 81827, Exp 8/2020; 111872, Exp 11/2020; 41970, Exp 4/2021; 519104, Exp 5/2021; b) 81827, Exp 8/2020; 111872, Exp 11/2020; 41970, Exp 4/2021.
Where it was sold
OR
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-0781-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 14, 2019
- FDA report date
- Jan 22, 2020
- Quantity
- 44,373 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Wisconsin Pharmacal Company, LLC
Original FDA data
Every field from FDA enforcement report D-0781-2020, exactly as published.
Show all FDA fields
- City
- Jackson
- State
- WI
- Status
- Terminated
- Country
- United States
- Event ID
- 84291
- Address
- N168w22223 Main St
- Code information
- Lot #: a) 81827, Exp 8/2020; 111872, Exp 11/2020; 41970, Exp 4/2021; 519104, Exp 5/2021; b) 81827, Exp 8/2020; 111872, Exp 11/2020; 41970, Exp 4/2021.
- Postal code
- 53037
- Report date
- Jan 22, 2020
- Product type
- Drugs
- Recall number
- D-0781-2020
- Classification
- Class II
- Recalling firm
- Wisconsin Pharmacal Company, LLC
- Product quantity
- 44,373 cartons
- Termination date
- Nov 6, 2020
- Reason for recall
- cGMP violations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Yeast Arrest, Homeopathic Formula, Vaginal Support suppositories, packaged in a) 14-count carton (NDC 68093-0730-1 and 68093-0730-3), b) 28-count carton (NDC 68093-0730-2 and 68093-0730-4), Manufactured for: Vitanica, 12401 SW Leveton Drive, Tualatin, OR 97062.
- Distribution pattern
- OR
- Recall initiation date
- Nov 14, 2019
- Initial firm notification
- Letter
- Center classification date
- Jan 16, 2020