Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)
This recall is currently active, issued June 23, 2025. It was issued by Recordati Rare Diseases Inc..
- Company
- Recordati Rare Diseases Inc.
- Recall Initiated
- June 11, 2025
- Posted
- June 23, 2025
- Recall Number
- Z-2012-2025
- Quantity
- 3,754 boxes (120,128 doses)
- Firm Location
- Bridgewater, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Lot / Code Info
UDI-DI: 5060146293129. Lot Numbers: 001U002U, 001U002UA. Expiration 2026-10
Root Cause
Device Design
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.