Drug product
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.
D-1627-2020
Product summary
- Event
- Event 86405
- Status
- Terminated
- Classification
- Class II
- Quantity
- a. 37,000 boxes; b. 45,000 boxes; c. 6,100 boxes
- Official record key
drug-enforcement:D-1627-2020
Official wording
Reason: Marketed without an Approved NDA/ANDA.
Code information: Lot #: a) 2PA20021, 2PA20061; b) D-160, D-155, D-162; c) 7PA20071.
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Unknown
Marketed without an Approved NDA/ANDA.