Drug & medication recalls High risk

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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