Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate,
Summary
The FDA issued a Class II for Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous sol by RECORDATI RARE DISEASES INC.. Reason: Out of specification stability test result for the Caphosol B solution from process validation lots.
Details
Source
Device Recall
External ID
Z-2012-2025
Action Date
2025-07-02
Status
Ongoing
Category
device
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)
Lot/Code Info: UDI-DI: 5060146293129. Lot Numbers: 001U002U, 001U002UA. Expiration 2026-10
Quantity Affected: 3,754 boxes (120,128 doses)
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-11
Company
Bridgewater, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 160 device recalls issued in the same week, part of 403 device-related FDA actions this month.
RECORDATI RARE DISEASES INC. has 2 FDA actions in our database, including 1 recall.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (RECORDATI RARE DISEASES INC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does RECORDATI RARE DISEASES INC. have FDA actions?
RECORDATI RARE DISEASES INC. has 2 FDA actions in our database, including 1 recall and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2012-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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