Recalls / Class II

Class IID-0319-2023

Product

TPN 107gm/AA, 200gm/DEX, 50gm/LIP 2250mL, (b) 108GM/AA, 330GM/DEX 3000ML, (c) 108GM/AA, 330GM/DEX, 60GM/LIP 3000ML, (d) 37GM/AA, 160GM/DEX 1450ML, (e) 37GM/AA, 160GM/DEX, 25GM/LIP 1450ML, (f) 74-100GM OF PROTEIN B4197 74 Gm, (g) 75GM/AA, 200GM/DEX, 43GM/LIP 2500ML, (h) 90GM/AA ; 255GM/DEX ; 50GM/LIP 3500 ml, (i) 90GM/AA ; 255GMDEX 3500 ml, (j) TPN AA 100GM DEX: 320GM LIP: 50GM 2400ML, (k) TPN AA 30GM DEX: 145GM 1210ML, (l) TPN AA 30GM DEX: 145GM LIP: 35GM 1210ML, (m)TPN AA 42GM DEX: 432GM 2070ML, (n) TPN AA 50GM DEX: 130GM 2500ML, (o) TPN AA 55GM DEX:180GM 1000ML, (p) TPN AA 70GM DEX:290GM 2100ML, (q) TPN AA 70GM DEX:290GM 2500ML, (r) TPN AA 80GM DEX:200GM 1900ML, (s) TPN AA 80GM DEX:200GM LIP:38GM 1900ML, (t) TPN AA 30GM ; DEX 82GM ; IN 890 ml, (u) TPN AA 30GM ; DEX 82GM ; LIP 18GM IN 890 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

111 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-0319-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.