Drug Enforcement D-0630-2024

Lack of Assurance of Sterility

Status

Terminated

Classification

Class II

Report Date

August 14, 2024

Termination Date

March 28, 2025

Product Information

Product description
Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial, For IM or SQ use only, RX only, Compounded by: Empower Pharmacy 7601 N Sam Houston Pkwy W Ste 100, Houston, TX 77064
Product quantity
2,797
Reason for recall
Lack of Assurance of Sterility
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
EMPOWER CLINIC SERVICES LLC
Address
7601 N Sam Houston Pkwy W Ste 100

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

Codes & Dates

Recall number
D-0630-2024
Event ID
95079
Recall initiation date
August 2, 2024
Center classification date
August 8, 2024
Code info
Lot #: 179338, Beyond use date: 08/14/2024
More code info
—