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RECORDATI RARE DISEASES INC. recalls Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate,
Recalled July 2, 2025 · FDA recall Z-2012-2025 · RECORDATI RARE DISEASES
Hazard
Out of specification stability test result for the Caphosol B solution from process validation lots · FDA Class II
Units
3,754 boxes (120,128 doses)
Sold at
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.
Description
Out of specification stability test result for the Caphosol B solution from process validation lots
Product
Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)
Manufacturer(s)
RECORDATI RARE DISEASES INC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →