RECORDATI RARE DISEASES INC.: Device Recall
Recall #Z-2012-2025 · 06/11/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2012-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- RECORDATI RARE DISEASES INC.
- Status
- Ongoing
- Date Initiated
- 06/11/2025
- Location
- Bridgewater, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,754 boxes (120,128 doses)
Reason for Recall
Out of specification stability test result for the Caphosol B solution from process validation lots
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)
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.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.