September 2020 FDA Recall Drug by Ph-d Feminine Health
D-1627-2020 - Marketed without an Approved NDA/ANDA.

This Class II drug recall was voluntarily initiated by Ph-d Feminine Health on September 2, 2020 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1627-2020

Reason for Recall
Marketed without an Approved NDA/ANDA.
Initiated
09-02-2020
Reported
10-07-2020
Quantity
a. 37,000 boxes; b. 45,000 boxes; c. 6,100 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86405
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
pH-D Feminine Health
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the U.S.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-25-2022
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# : a) 2PA20021, 2PA20061; b) D-160, D-155, D-162; c) 7PA20071.