Recalls / Class II
Class IID-0320-2023
Product
TPN (a) 115GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (b)90GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (c) TPN AA: 100GM DEX: 105GM 2700ML, (d) TPN AA: 100GM DEX: 105GM LIP: 45GM 2700ML, (e) TPN: AA100GM ; DEX185GM ; LIP50GM IN 1500ML, (f) TPN: AA 150GM ; DEX 220GM ; LIP 45GM IN 2400 ml, (g) TPN: AA 60GM ; DEX 200GM ; LIP 30GM IN 1500 ml, Rx only, use with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
- Affected lot / code info
- Beyond Use Date: December 24-31, 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
- 31 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-0320-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.