The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1184-2022·Announced 2022-07-13

Boric Acid Vaginal Suppositories Recalled Due to Manufacturing Control Defects

Wedgewood Village Pharmacy is recalling Boric Acid 600 mg vaginal suppositories (Lot #000-03843532) nationwide due to insanitary manufacturing conditions and lack of processing controls detected during an FDA inspection. No illnesses have been reported.

The agency’s classification

FDA (Drugs): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for manufacturing defects (insanitary conditions and lack of processing controls) in a vaginal medication product. No illnesses or injuries have been reported. Per the rubric, recalls involving risk-of-harm products where injury has not yet been reported receive a score of 3 (High).

Plain-English summary

Wedgewood Village Pharmacy, LLC is recalling Boric Acid 600 mg per suppository (14 suppositories per box) distributed nationwide. The recall was initiated because the FDA observed insanitary conditions and a lack of processing controls during a recent inspection of the manufacturing facility. These conditions could potentially compromise the safety and efficacy of the product.

The recalled product is identified by Lot # 000-03843532 with an expiration date of September 6, 2022. The product was distributed nationwide throughout the United States. If you have purchased this product, check the lot number on your box.

Consumers who have this product should stop using it and dispose of it according to local regulations. If you have questions about this recall, contact Wedgewood Village Pharmacy, LLC at 405 Heron Drive, Suite 200, Swedesboro, NJ 08085.

This is a Class II recall issued by the U.S. Food and Drug Administration (FDA Recall Number: D-1184-2022).

The recalled product

Product
Boric Acid 600 mg per suppository, 14 Vaginal Suppositories per box, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
Manufacturer
Wedgewood Village Pharmacy, LLC
Category
Drug — Vaginal Medication
Hazard
Affected units
14

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 (1)

  • Lot#: 000-03843532 Exp Date: 09/6/22

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Wedgewood Village Pharmacy, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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