RECORDATI RARE DISEASES INC. recalls Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate,…
- Recall date
- June 11, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2012-2025
- FDA classification
- Class II
- Brand / firm
- RECORDATI RARE DISEASES INC.
- Sold / distributed
- 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.
Why it was recalled
Out of specification stability test result for the Caphosol B solution from process validation lots
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)
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