FDA-Device2025-07-02Class II
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.
Hazard
Out of specification stability test result for the Caphosol B solution from process validation lots
Sold states
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.
Affected count
3,754 boxes (120,128 doses)
Manufactured in
440 Us Highway 22 Ste 205, Bridgewater, NJ, United States
Products
Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2012-2025Don't want to check this manually?
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