Recall Z-2012-2025 · LFD Saliva, Artificial
RECORDATI RARE DISEASES INC.
Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)
| Date | Jun 23, 2025 (initiated Jun 11, 2025) |
| Status | Open, Classified |
| Reason | Out of specification stability test result for the Caphosol B solution from process validation lots |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K234015 | Caphosol® Artifical Saliva (32 doses sachet box) Eusa Pharma (Uk) Limited, Mar 11, 2024 |