Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachet...
FDA Recall #Z-2012-2025 — Class II — June 11, 2025
Product Description
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
Recalling Firm
RECORDATI RARE DISEASES INC. — Bridgewater, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3,754 boxes (120,128 doses)
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.
Code Information
UDI-DI: 5060146293129. Lot Numbers: 001U002U, 001U002UA. Expiration 2026-10
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated