The Recall Desk
HighFDA (Drugs)·D-1183-2022·Announced 2022-07-13

Boric Acid 600 mg Capsules Recalled for Insanitary Manufacturing Conditions

The FDA has recalled Boric Acid 600 mg capsules (Lot #000-03868160, Exp: 09/14/22) manufactured by Wedgewood Village Pharmacy due to insanitary conditions and lack of processing controls observed during FDA inspection. The recalled product was distributed nationwide.

What this means for you

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: FDA Class II recall for manufacturing quality defect. No illnesses reported, but insanitary conditions during manufacturing create a risk of product contamination, meeting the criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Wedgewood Village Pharmacy, LLC has recalled Boric Acid 600 mg capsules (Lot #000-03868160, Exp: 09/14/22) due to lack of processing controls and insanitary conditions observed during a recent FDA inspection.

The affected product was distributed nationwide. The insanitary manufacturing conditions constitute a potential quality and safety concern.

Consumers who have this product should stop use and consult their healthcare provider. For further information or instructions regarding return of the product, contact Wedgewood Village Pharmacy.

The recalled product

Product
Boric Acid 600 mg capsules, 14 capsules per box, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
Manufacturer
Wedgewood Village Pharmacy, LLC
Category
Drug
Hazard
  • manufacturing-defect
  • insanitary-conditions

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 (2)

  • Lot#: 000-03868160
  • Exp Date: 09/14/22

Distribution

Distributed nationwide across the United States.

Related recalls

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