Summary
The FDA issued a Class II for Diasol Acid Concentrate REF G100325-10Dex 100 by Diasol, Inc. Reason: Due to labeling issue. The box label is different that the gallon label in that gallon label shows a lower Calcium concentration than the box label..
Details
Source
Device Recall
External ID
Z-0207-2025
Action Date
2024-10-30
Status
Ongoing
Category
device
Product Description
Diasol Acid Concentrate REF G100325-10Dex 100
Lot/Code Info: Catalog Number: G100325-10Dex100 UDI code: B467100325101004 Lot Number:PHS06011/061722
Quantity Affected: 852 gallon bottles
Reason for Recall
Due to labeling issue. The box label is different that the gallon label in that gallon label shows a lower Calcium concentration than the box label.
Distribution
U.S. Nationwide distribution in the state of AZ.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-27
Company
Phoenix, AZ
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 253 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Diasol, Inc has 7 FDA actions in our database, including 7 recalls.
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 (Diasol, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Diasol, Inc have FDA actions?
Diasol, Inc has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0207-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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