Status
Completed
Drug Enforcement D-0318-2023
Lack of sterility assurance
Classification
Class II
Report Date
February 22, 2023
Termination Date
—
Product Information
- Product description
- TPN (a) 100GM/AA, 285GM/DEX, (b)55GM/LIP 2300ML, (c)55GM/AA 285GM/DEX 50GM/LIP1800ML, (d)TPN AA:100GM DEX:250GM LIP:50GM 2400ML, (e) 55GM DEX:285GM 1800ML, Rx Only, use with Curlin pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
- Product quantity
- 26 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-0318-2023
- Event ID
- 91466
- Recall initiation date
- December 27, 2022
- Center classification date
- February 15, 2023
- Code info
- Beyond Use Date: December 24-3 , 2022
- More code info
- —