pH-D Feminine Health Boric Acid Vaginal Suppositories, 24 vaginal suppositories per box, 600 mg e...
FDA Recall #D-1627-2020 — Class II — September 2, 2020
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.
Recalling Firm
pH-D Feminine Health — Madison, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
a. 37,000 boxes; b. 45,000 boxes; c. 6,100 boxes
Distribution
Nationwide in the U.S.
Code Information
Lot #: a) 2PA20021, 2PA20061; b) D-160, D-155, D-162; c) 7PA20071.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.