ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA

FDA Recall #D-0067-2024 — Class I — September 29, 2023

Recall #D-0067-2024 Date: September 29, 2023 Classification: Class I Status: Terminated

Product Description

ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA

Reason for Recall

Microbial contamination of Non-Sterile Products

Recalling Firm

Biomic Sciences, LLC dba ION Intelligence of Nature — Charlottesville, VA

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

N/A

Distribution

Nationwide in the United States and to Canada, New Zealand, Australia, Indonesia, Malaysia, Great Britain, and the Netherlands

Code Information

All lots within expiry.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated