FDA Drug Recalls

Recalls / Class II

Class IID-0323-2023

Product

VANCOMYCIN (a)700 MG NS 140ML, (b) 1000MG IN NS 200ML, abtibiotic, Rx only, use with home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

Affected lot / code info
Beyond Use Date: December 28-31, 2022

Why it was recalled

Lack of sterility assurance

Recalling firm

Firm
Sentara Infusion Services
Notification channel
Telephone
Type
Voluntary: Firm initiated
Address
535 Independence Pkwy Ste 300, N/A, Chesapeake, Virginia 23320-5176

Distribution

Quantity
18 bags
Distribution pattern
Dispensed to Patients Nationwide.

Timeline

Recall initiated
2022-12-27
FDA classified
2023-02-15
Posted by FDA
2023-02-22
Terminated
2026-02-20
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0323-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls