Class II

Medical Device Recall: Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)

RECORDATI RARE DISEASES INC. · June 11, 2025

Reason for Recall

Out of specification stability test result for the Caphosol B solution from process validation lots

Distribution

Worldwide - US Nationwide distribution in the states of GA, OH, TN, TX, VA and the countries of Germany, France, Italy, Portugal, Spain, Sweden, United Kingdom.

States Affected

NATIONWIDE

Quantity Affected

3,754 boxes (120,128 doses)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2012-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

RECORDATI RARE DISEASES INC. Medical Device Recall: Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium) | SafeCheck