Drug Enforcement D-0663-2024

Lack of Assurance of Sterility

Status

Terminated

Classification

Class II

Report Date

October 2, 2024

Termination Date

February 14, 2025

Product Information

Product description
Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX Only, Compounded by: Empower Pharmacy 5980 W Sam Houston Pkwy N Ste 300, Houston, TX 77041 NDC 72627-2424-1.
Product quantity
450
Reason for recall
Lack of Assurance of Sterility
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Empower Pharmacy
Address
5980 W Sam Houston Pkwy N Ste 300

United States
Voluntary / Mandated
—
Status date
—

Codes & Dates

Recall number
D-0663-2024
Event ID
95304
Recall initiation date
September 5, 2024
Center classification date
September 20, 2024
Code info
Product lot number: 609763 Beyond Use Date: 04/18/2025
More code info
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