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Recall Observatory FDA recall evidence

Drug product

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.

D-0663-2024

September 05, 2024

Class II

Product summary

Firm
Empower Pharmacy
Event
Event 95304
Status
Terminated
Classification
Class II
Quantity
450
Official record key
drug-enforcement:D-0663-2024

Official wording

Reason: Lack of Assurance of Sterility

Code information: Product lot number: 609763 Beyond Use Date: 04/18/2025

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility