Drug Enforcement D-0291-2023

Lack of sterility assurance

Status

Completed

Classification

Class II

Report Date

February 22, 2023

Termination Date

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Product Information

Product description
Ertapenem (Invanz) 1GM NS 100ML, antibiotic, use with home pump, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Product quantity
22 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-0291-2023
Event ID
91466
Recall initiation date
December 27, 2022
Center classification date
February 15, 2023
Code info
Beyond Use Date: December 24-31, 2022
More code info
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