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  3. Recall Enforcement Event ID: 96290

Recall Enforment Report D-0300-2025

Recall Details

Multi event Drug Recall Enforcement Report Class I voluntary initiated by Ascent Consumer Products Inc., originally initiated on 01-28-2025 for the 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 The product was recalled due to microbial contamination of non-sterile products: bacterial contamination with staphylococcus aureus. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0300-202501-28-202504-02-2025Class IunknownSinuCleanse 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 4Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureusOngoing
D-0301-202501-28-202504-02-2025Class IunknownSinuCleanse 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 7Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureusOngoing
D-0299-202501-28-202504-02-2025Class I4,176 cartonsSinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 Soft tip Squeeze Bottle, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00104 1Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureusOngoing