Recalls / Class II
Class IID-0662-2022
Product
Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles, Rx only, Family Pharmacy of Statesville, Inc.
- Affected lot / code info
- Lot: 07312020@2 BUD: 9/14/2020
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Family Pharmacy of Statesville
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 3478 E Broad St, N/A, Statesville, North Carolina 28625-4523
Distribution
- Quantity
- 3 bottles
- Distribution pattern
- NC only
Timeline
- Recall initiated
- 2020-08-06
- FDA classified
- 2022-03-17
- Posted by FDA
- 2022-03-23
- Terminated
- 2023-08-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0662-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.