Bridgewater, NJ, United States
RECORDATI RARE DISEASES INC. recalls
1 recall recorded since 2018, most recently on 11 June 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 11 June 2025
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2012-2025
- Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.