Drug Enforcement D-0297-2023

Lack of sterility assurance

Status

Completed

Classification

Class II

Report Date

February 22, 2023

Termination Date

Product Information

Product description
IMIPENEM/CILASTATIN 2000MG IN NS 400ML, antibiotic, Rx Only, use with a Curlin Pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, NDC# 63323-0322-25
Product quantity
7 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-0297-2023
Event ID
91466
Recall initiation date
December 27, 2022
Center classification date
February 15, 2023
Code info
Beyond Use Date: December 25-30, 2022
More code info