Status
Completed
Drug Enforcement D-0322-2023
Lack of sterility assurance
Classification
Class II
Report Date
February 22, 2023
Termination Date
—
Product Information
- Product description
- Vancomycin (a) 1.25GM IN NS 250ML, (b) 1.5GM IN NS 300ML, (c) 1000MG IN NS 200ML (d) 2GM IN 400ML NS, (e) 900MG IN NS 180ML, (f) 500 MG NS 100ML, (g) 750 MG NS 150ML, antibiotic, Rx only, use with home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
- Product quantity
- 155 bags
- Reason for recall
- Lack of sterility assurance
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- Dispensed to Patients Nationwide.
Location & Firm
- Recalling firm
- Sentara Infusion Services
- Address
-
535 Independence Pkwy Ste 300, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0322-2023
- Event ID
- 91466
- Recall initiation date
- December 27, 2022
- Center classification date
- February 15, 2023
- Code info
- Beyond Use Date: December 24-31, 2022
- More code info
- —