Why it was recalled
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Product description
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 numbers, UPCs & expiration codes
Lot# 024122661Al, Exp Date 12/2027
Where it was sold
Nationwide in the US.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0300-2025
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Jan 28, 2025
- FDA report date
- Apr 2, 2025
- Quantity
- unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ascent Consumer Products Inc.
Original FDA data
Every field from FDA enforcement report D-0300-2025, exactly as published.
Show all FDA fields
- City
- Melville
- State
- NY
- Status
- Ongoing
- Country
- United States
- Event ID
- 96290
- Address
- 105 Baylis Rd
- Code information
- Lot# 024122661Al, Exp Date 12/2027
- Postal code
- 11747-3833
- Report date
- Apr 2, 2025
- Product type
- Drugs
- Recall number
- D-0300-2025
- Classification
- Class I
- Recalling firm
- Ascent Consumer Products Inc.
- Product quantity
- unknown
- Reason for recall
- Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the US.
- Recall initiation date
- Jan 28, 2025
- Initial firm notification
- Center classification date
- Mar 25, 2025