pH-D Boric Acid Vaginal Suppositories Recalled for Lack of FDA Approval
pH-D Feminine Health is recalling Boric Acid Vaginal Suppositories because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The specific reason for the recall is a regulatory violation (lack of NDA/ANDA approval) rather than a reported physical defect or contamination causing immediate harm.
Plain-English summary
pH-D Feminine Health, LLC is recalling pH-D Feminine Health Boric Acid Vaginal Suppositories, 24 vaginal suppositories per box, 600 mg each. The product is identified by UPC Code 3 49597 00044 5.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The affected lots are 2PA20021, 2PA20061, D-160, D-155, D-162, and 7PA20071. The total quantity involved is 88,100 boxes, which were distributed nationwide in the U.S.
Consumers who have purchased these products should stop using them and contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- 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.
- Manufacturer
- pH-D Feminine Health
- Category
- Drug — Vaginal Suppositories
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot #: a) 2PA20021
- 2PA20061
- b) D-160
- D-155
- D-162
- c) 7PA20071.
Distribution
Distributed nationwide across the United States.
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