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Recall Observatory FDA recall evidence

Drug product

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

D-0318-2023

December 27, 2022

Class II

Product summary

Firm
Sentara Infusion Services
Event
Event 91466
Status
Terminated
Classification
Class II
Quantity
26 bags
Official record key
drug-enforcement:D-0318-2023

Official wording

Reason: Lack of sterility assurance

Code information: Beyond Use Date: December 24-3 , 2022

Distribution pattern: Dispensed to Patients Nationwide.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility