Zinc Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 334
Summary
The FDA issued a Class II for Zinc Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 28 by GenoGenix LLC. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0084-2026
Action Date
2025-10-15
Status
Ongoing
Category
drug
Product Description
Zinc Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lot/Code Info: All lots within expiry.
Reason for Recall
Lack of Assurance of Sterility
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-30
Company
Boca Raton, FL
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 92 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
GenoGenix LLC has 57 FDA actions in our database, including 57 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 (GenoGenix LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GenoGenix LLC have FDA actions?
GenoGenix LLC has 57 FDA actions in our database, including 57 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0084-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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