Drug product
SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 kettle style Neti Pot, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00102 7
D-0301-2025
Product summary
- Event
- Event 96290
- Status
- Ongoing
- Classification
- Class I
- Quantity
- unknown
- Official record key
drug-enforcement:D-0301-2025
Official wording
Reason: Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Code information: Lot# 024122661Al, Exp Date 12/2027
Distribution pattern: Nationwide in the US.
Derived failure modes
-
Microbial contamination
Microbial Contamination