Reported Jul 2, 2025 · Ongoing
Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate,…
Recordati Rare Diseases Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: RECORDATI RARE DISEASES INC. · 440 Us Highway 22 Ste 205 · Bridgewater, NJ · 08807-2477
Is this the product you have?
- Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)
- Lot codes and dates
- UDI-DI5060146293129
- Lot Numbers
001U002U001U002UA. Expiration 2026-10
- Amount recalled
- 3,754 boxes (120,128 doses)
Where it was sold
Why it was recalled
Out of specification stability test result for the Caphosol B solution from process validation lots
This product could cause temporary or reversible health problems — stop using it.
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