Recall Z-2012-2025— RECORDATI RARE DISEASES INC.

Name: FDA recall Z-2012-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-11

Class II · Ongoing

Class II FDA medical device recall by RECORDATI RARE DISEASES INC., initiated 2025-06-11. It names one FDA 510(k) clearance: K234015. 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). Reason: Out of specification stability test result for the Caphosol B solution from process validation lots.

Recalling firm: RECORDATI RARE DISEASES INC.
Classification: Class II
Status: Ongoing
Initiated: 2025-06-11
Firm location: Bridgewater, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K234015 — Caphosol® Artifical Saliva (32 doses sachet box)Eusa Pharma (Uk) Limited·cleared 2024-03-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.