FDA Drug Recalls

Recalls / Class II

Class IID-0285-2023

Product

D5W1/2NS W/ 77MEQ OF SOD ACETATE 1000ML, Hydration, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

Affected lot / code info
Beyond Use Date: December 29-31, 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
8 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-0285-2023. 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