Class II · Moderate risk
Estriol 1mg/gm
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Boric Acid 600 mg per suppository
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Boric Acid 600 mg per suppository, 14 Vaginal Suppositories per box, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
- Recalling firm
- Wedgewood Village Pharmacy, LLC
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1184-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Wedgewood Village Pharmacy, LLC
All 2022 recalls
Class II · Moderate risk
Estriol 1mg/gm
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk
Boric Acid 600 mg capsules
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk
Doxycycline
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
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All cgmp deviation recalls
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