Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 5060146293129. Lot Numbers: 001U002U, 001U002UA. Expiration 2026-10
- 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:
- RECORDATI RARE DISEASES INC.
- Reason for Recall:
- Out of specification stability test result for the Caphosol B solution from process validation lots
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)
Product Codes/Lot Numbers:
UDI-DI: 5060146293129. Lot Numbers: 001U002U, 001U002UA. Expiration 2026-10
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2012-2025