Recalls / Class II
Class IID-0321-2023
Product
TPN (a) 95GM/AA, 385/DEX, 50GM/LIP 1800ML, (b)TPN AA:100GM DEX:250GM LIP:50GM 2400ML, (c) TPN: AA 80GM ; DEX 320GM ; LIP 50GM IN 2300 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 25-31, 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
- 24 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-0321-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.