SinuCleanse Premixed SALINE PACKETS for Nasal Wash System recalled over sterility concerns
- Recall date
- January 28, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Ascent Consumer Products Inc. recalls SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) for Nasal Wash Syst…
- Recall number
- D-0300-2025
- FDA classification
- Class I
- Brand / firm
- Ascent Consumer Products Inc.
- Sold / distributed
- Nationwide in the US.
Why it was recalled
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) for Nasal Wash System, 60-count All Natural USP Grade Saline Packets, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00103 4
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