FDAHealthJanuary 28, 2025
Ascent Consumer Products Inc. — 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
⚠️ Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 28, 2025
Nationwide in the US.
What's affected?
- Product
- 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
- Lot code
- 024122661Al
Additional details
Lot# 024122661Al, Exp Date 12/2027
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: unknown.
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