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Z-2012-2025 Class II Ongoing

Recalled by RECORDATI RARE DISEASES INC. — Bridgewater, NJ

FDA device recall Z-2012-2025 was initiated by RECORDATI RARE DISEASES INC. on June 11, 2025 and is designated Class II. Reason for recall: Out of specification stability test result for the Caphosol B solution from process validation lots The recall status is ongoing. Affected quantity: 3,754 boxes (120,128 doses).

Recall Details

Product Type: Devices
Report Date: July 2, 2025
Initiation Date: June 11, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3,754 boxes (120,128 doses)

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

Distribution Pattern

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.

Code Information

UDI-DI: 5060146293129. Lot Numbers: 001U002U, 001U002UA. Expiration 2026-10