Class II · Moderate risk
Restore Sinus Spray
Microbial contamination of Non-Sterile Products
ION*Sinus Spray
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Microbial contamination of Non-Sterile Products
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
What was recalled
ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA
- Recalling firm
- Biomic Sciences, LLC dba ION Intelligence of Nature
- Origin
- VA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0067-2024 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Biomic Sciences, LLC dba ION Intelligence of Nature
All 2023 recalls
Class II · Moderate risk
ION* Sinus Support Nasal Spray
Microbial contamination of Non-Sterile Products
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Class II · Moderate risk
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Class II · Moderate risk
Quality Choice No Drip Extra Moisturizing Nasal Pump Mist…
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Class II · Moderate risk
Premier Value Tussin Cough DM
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Class II · Moderate risk
Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
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