Drug Enforcement D-0236-2023

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Status

Terminated

Classification

Class II

Report Date

February 1, 2023

Termination Date

July 31, 2024

Product Information

Product description
SEMAGLUTIDE 0.5MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 1MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 2MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 4MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 5.4MG/ML (0.5ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Product quantity
N/A
Reason for recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Recall initiation reason
—
Initial firm notification
Telephone
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Pharmacy Innovations
Address
2936 W 17th St, N/A

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

Codes & Dates

Recall number
D-0236-2023
Event ID
91332
Recall initiation date
December 22, 2022
Center classification date
January 26, 2023
Code info
t20221026@52 t20221102@11 t20221004@44 t20221116@36 t20221011@36
More code info
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