Class II · Moderate risk Terminated
Boric Acid 600 mg per suppository
Reason Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
pH-D Feminine Health Boric Acid Vaginal Suppositories
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Marketed without an Approved NDA/ANDA.
What 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.
- Recalling firm
- pH-D Feminine Health
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1627-2020
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Boric recalls
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Class II · Moderate risk Terminated
Boric Acid 600 mg capsules
Reason Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk Terminated
Iodochlorhydroxyquin 3%/ Boric Acid 10%/ Amphotericin 5% Otic…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk Terminated
All boric acid Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Boric Acid 1% Ear Drop
Reason Lack of Assurance of Sterility
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