Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC 0487-9003-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. For respiratory therapy, Solium Chloride Inhalation Solution USP, 3% is used in conjunction with a nebulizer
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Number N4745A, Exp 09/16
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Nephron Pharmaceuticals Corp.
- Reason for Recall:
- Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC 0487-9003-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. For respiratory therapy, Solium Chloride Inhalation Solution USP, 3% is used in conjunction with a nebulizer
Product Codes/Lot Numbers:
Lot Number N4745A, Exp 09/16
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2053-2016
Related Recalls
Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial.
Discoloration
Discoloration