D-1627-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 7, 2020
- Initiation Date
- September 2, 2020
- Termination Date
- February 25, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a. 37,000 boxes; b. 45,000 boxes; c. 6,100 boxes
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.
Reason for Recall
Marketed without an Approved NDA/ANDA.
Distribution Pattern
Nationwide in the U.S.
Code Information
Lot #: a) 2PA20021, 2PA20061; b) D-160, D-155, D-162; c) 7PA20071.