PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: October 2, 2024 Initiated: September 5, 2024 #D-0663-2024

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.

Reason for Recall

Lack of Assurance of Sterility

Details

Recalling Firm
Empower Pharmacy
Units Affected
450
Distribution
Nationwide
Location
Houston, TX

Frequently Asked Questions

What product was recalled?
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.. Recalled by Empower Pharmacy. Units affected: 450.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on October 2, 2024. Severity: Moderate. Recall number: D-0663-2024.