[pending] Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets S
Pending LLM rewrite. Source: FDA_DEVICE Z-2012-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Out of specification stability test result for the Caphosol B solution from process validation lots
The recalled product
- 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)
- Manufacturer
- RECORDATI RARE DISEASES INC.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 5060146293129. Lot Numbers: 001U002U
- 001U002UA. Expiration 2026-10
Distribution
Distributed nationwide across the United States.
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