Drug Enforcement D-0281-2023

Lack of sterility assurance

Status

Completed

Classification

Class II

Report Date

February 22, 2023

Termination Date

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Product Information

Product description
CEFOXITIN (a) 1GM IN NS 50ML,(b) 2GM IN NS 100ML, used with a home pump. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
Product quantity
3 bags
Reason for recall
Lack of sterility assurance
Recall initiation reason
—
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-0281-2023
Event ID
91466
Recall initiation date
December 27, 2022
Center classification date
February 15, 2023
Code info
Beyond Use date December 30, 2022
More code info
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