PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: October 7, 2020 Initiated: September 2, 2020 #D-1627-2020

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.

Details

Recalling Firm
pH-D Feminine Health
Units Affected
a. 37,000 boxes; b. 45,000 boxes; c. 6,100 boxes
Distribution
Nationwide in the U.S.
Location
Madison, TN

Frequently Asked Questions

What product was recalled?
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.. Recalled by pH-D Feminine Health. Units affected: a. 37,000 boxes; b. 45,000 boxes; c. 6,100 boxes.
Why was this product recalled?
Marketed without an Approved NDA/ANDA.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 7, 2020. Severity: Moderate. Recall number: D-1627-2020.