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)

Hazard

Out of specification stability test result for the Caphosol B solution from process validation lots

Details from the source

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. Quantity: 3,754 boxes (120,128 doses) Lot/code info: UDI-DI: 5060146293129. Lot Numbers: 001U002U, 001U002UA. Expiration 2026-10

UPC codes

5060146293129

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.