SinuCleanse Nasal Saline Packets Recalled for Bacterial Contamination
SinuCleanse Premixed Saline Packets sold nationwide are being recalled due to contamination with Staphylococcus aureus, a bacterium that can cause infection.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall carries FDA Class I classification, which establishes a minimum severity of Severe (4) per the rubric. No deaths or reported illnesses are documented, so it does not meet the criteria for Critical (5).
Plain-English summary
SinuCleanse Premixed SALINE PACKETS have been recalled due to contamination with Staphylococcus aureus. The product is intended for use in a Nasal Wash System and contains sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg per packet.
The recalled product is available in 60-count packages of All Natural USP Grade Saline Packets. Each packet contains 0.1 oz (3g). The manufacturer and distributor is Ascent Consumer Products Inc., located in Melville, New York. The affected lot is Lot# 024122661Al with an expiration date of December 2027.
The product has been distributed nationwide in the United States. Consumers with this product should discontinue use.
The recalled product
- 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
- Manufacturer
- Ascent Consumer Products Inc.
- Category
- Drug — Nasal Irrigation
- Hazard
- staph-aureus
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot# 024122661Al
- Exp Date 12/2027
Distribution
Distributed nationwide across the United States.
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