FDA Medical devices recall ·
Caphosol Artificial Saliva (32 doses sachet box) recall
- Recall number
- Z-2012-2025
- Date
- (initiated June 11, 2025)
- Company / brand
- Recordati Rare Diseases Inc.
440 Us Highway 22 Ste 205, Bridgewater, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3,754 boxes (120,128 doses)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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)
Why was it recalled?
Out of specification stability test result for the Caphosol B solution from process validation lots
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 5060146293129. Lot Numbers: 001U002U, 001U002UA. Expiration 2026-10
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.
States: Georgia Ohio Tennessee Texas Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2012-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.