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Class II: temporary or reversible health riskTerminated

pH-D Feminine Health Boric Acid Vaginal Recall

pH-D Feminine Health Boric Acid Vaginal Suppositories, 24 vaginal suppositories per box…

pH-D Feminine Health · Madison, TN

Risk level
Class II
Reported by FDA
Oct 7, 2020
Recall ID
D-1627-2020
Check your lot numberHow we source this data

Summary

pH-D Feminine Health recalled pH-D Feminine Health Boric Acid Vaginal starting Sep 2, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1627-2020 on Oct 7, 2020. Reason: Marketed without an Approved NDA/ANDA. Status: Terminated.

Why it was recalled

Marketed without an Approved NDA/ANDA.

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.

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide in the U.S.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1627-2020
Classification
Class II
Status
Terminated
Recall initiated
Sep 2, 2020
FDA report date
Oct 7, 2020
Quantity
a. 37,000 boxes; b. 45,000 boxes; c. 6,100 boxes
Recall type
Voluntary: Firm initiated
Recalling firm
pH-D Feminine Health

Original FDA data

Every field from FDA enforcement report D-1627-2020, exactly as published.

Show all FDA fields
City
Madison
State
TN
Status
Terminated
Country
United States
Event ID
86405
Address
305 Williams Ave
Code information
Lot #: a) 2PA20021, 2PA20061; b) D-160, D-155, D-162; c) 7PA20071.
Postal code
37115-2626
Report date
Oct 7, 2020
Product type
Drugs
Recall number
D-1627-2020
Classification
Class II
Recalling firm
pH-D Feminine Health
Product quantity
a. 37,000 boxes; b. 45,000 boxes; c. 6,100 boxes
Termination date
Feb 25, 2022
Reason for recall
Marketed without an Approved NDA/ANDA.
Voluntary / mandated
Voluntary: Firm initiated
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.
Distribution pattern
Nationwide in the U.S.
Recall initiation date
Sep 2, 2020
Initial firm notification
E-Mail
Center classification date
Sep 30, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1627-2020, published Oct 7, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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