Drug Enforcement D-0321-2023

Lack of sterility assurance

Status

Completed

Classification

Class II

Report Date

February 22, 2023

Termination Date

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Product Information

Product description
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
Product quantity
24 bags
Reason for recall
Lack of sterility assurance
Recall initiation reason
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Initial firm notification
Telephone
Distribution pattern
Dispensed to Patients Nationwide.

Location & Firm

Recalling firm
Sentara Infusion Services
Address
535 Independence Pkwy Ste 300, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0321-2023
Event ID
91466
Recall initiation date
December 27, 2022
Center classification date
February 15, 2023
Code info
Beyond Use Date: December 25-31, 2022
More code info
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