Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate,
FDA device recall Z-2012-2025 · posted 2025-06-23 · Open, Classified
Recall details
- Recalling firm
- RECORDATI RARE DISEASES INC.
- Reason for recall
- Out of specification stability test result for the Caphosol B solution from process validation lots
- Action taken
- Recordati Rare Diseases Inc. notified consignees on about 06/11/2025 via emailed letter. Consignees were instructed to examine inventory for affected lots, discontinue using, dispensing and distributing the affected lots, and promptly return any inventory. Consignees were also instructed to complete and return the Recall Response Form as well as notify consignees if the affected lots were further distributed.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- LFD
- Quantity affected
- 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.
- Date initiated
- 2025-06-11
- Date posted
- 2025-06-23
- Location
- Bridgewater, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Caphosol® Artifical Saliva (32 doses sachet box) (K234015) | Eusa Pharma (Uk) Limited | 2024-03-11 |