Why it was recalled
Marketed without an Approved NDA/ANDA.
Product description
pH-D Feminine Health Boric Acid Vaginal Suppositories, 24 vaginal suppositories per box, 600 mg each, pH-D Feminine Health, LLC Madison, TN 37115, UPC Code: 3 49597 00044 5.
Lot numbers, UPCs & expiration codes
Lot #: a) 2PA20021, 2PA20061; b) D-160, D-155, D-162; c) 7PA20071.
Where it was sold
Nationwide in the U.S.
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-1627-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 2, 2020
- FDA report date
- Oct 7, 2020
- Quantity
- a. 37,000 boxes; b. 45,000 boxes; c. 6,100 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- pH-D Feminine Health
Original FDA data
Every field from FDA enforcement report D-1627-2020, exactly as published.
Show all FDA fields
- City
- Madison
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 86405
- Address
- 305 Williams Ave
- Code information
- Lot #: a) 2PA20021, 2PA20061; b) D-160, D-155, D-162; c) 7PA20071.
- Postal code
- 37115-2626
- Report date
- Oct 7, 2020
- Product type
- Drugs
- Recall number
- D-1627-2020
- Classification
- Class II
- Recalling firm
- pH-D Feminine Health
- Product quantity
- a. 37,000 boxes; b. 45,000 boxes; c. 6,100 boxes
- Termination date
- Feb 25, 2022
- Reason for recall
- Marketed without an Approved NDA/ANDA.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- pH-D Feminine Health Boric Acid Vaginal Suppositories, 24 vaginal suppositories per box, 600 mg each, pH-D Feminine Health, LLC Madison, TN 37115, UPC Code: 3 49597 00044 5.
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- Sep 2, 2020
- Initial firm notification
- Center classification date
- Sep 30, 2020