Z-2012-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 2, 2025
- Initiation Date
- June 11, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,754 boxes (120,128 doses)
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
Distribution Pattern
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