FDA recall Z-2012-2025

RECORDATI RARE DISEASES INC. · Class II · device

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)

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.

Key facts

Status: Ongoing
Initiation date: 2025-06-11
Report date: 2025-07-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2012-2025