Why it was recalled
Lack of Assurance of Sterility
Product description
Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles, Rx only, Family Pharmacy of Statesville, Inc.
Lot numbers, UPCs & expiration codes
Lot: 07312020@2 BUD: 9/14/2020
Where it was sold
NC only
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-0662-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 6, 2020
- FDA report date
- Mar 23, 2022
- Quantity
- 3 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Family Pharmacy of Statesville
Original FDA data
Every field from FDA enforcement report D-0662-2022, exactly as published.
Show all FDA fields
- City
- Statesville
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 89773
- Address
- 3478 E Broad St
- Code information
- Lot: 07312020@2 BUD: 9/14/2020
- Postal code
- 28625-4523
- Report date
- Mar 23, 2022
- Product type
- Drugs
- Recall number
- D-0662-2022
- Classification
- Class II
- Recalling firm
- Family Pharmacy of Statesville
- Product quantity
- 3 bottles
- Termination date
- Aug 15, 2023
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles, Rx only, Family Pharmacy of Statesville, Inc.
- Distribution pattern
- NC only
- Recall initiation date
- Aug 6, 2020
- Initial firm notification
- Telephone
- Center classification date
- Mar 17, 2022