FDA Drug recall D-0319-2023
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…
- FDA Drug
- Class II
- terminated
- Published 2023-02-22
On 2023-02-22 the FDA classified a Class II recall of 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… by Sentara Infusion Services, citing lack of sterility assurance.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0319-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-12-27 |
| Published | 2023-02-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sentara Infusion Services |
| Distribution | US |
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
Reason
Lack of sterility assurance
Identifiers
| code_info | Beyond Use Date: December 24-31, 2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0319-2023%22
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