Why it was recalled
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Product description
Boric Acid 600 mg per suppository, 14 Vaginal Suppositories per box, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
Lot numbers, UPCs & expiration codes
Lot#: 000-03843532 Exp Date: 09/6/22
Where it was sold
Products were distributed nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1184-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 10, 2022
- FDA report date
- Jul 13, 2022
- Quantity
- 14 suppositories
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Wedgewood Village Pharmacy, LLC
Original FDA data
Every field from FDA enforcement report D-1184-2022, exactly as published.
Show all FDA fields
- City
- Swedesboro
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90403
- Address
- 405 Heron Dr Ste 200
- Code information
- Lot#: 000-03843532 Exp Date: 09/6/22
- Postal code
- 08085-1749
- Report date
- Jul 13, 2022
- Product type
- Drugs
- Recall number
- D-1184-2022
- Classification
- Class II
- Recalling firm
- Wedgewood Village Pharmacy, LLC
- Product quantity
- 14 suppositories
- Termination date
- Feb 16, 2023
- Reason for recall
- Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Boric Acid 600 mg per suppository, 14 Vaginal Suppositories per box, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
- Distribution pattern
- Products were distributed nationwide in the USA.
- Recall initiation date
- Jun 10, 2022
- Center classification date
- Jul 7, 2022