Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edm
Summary
The FDA issued a Class III for Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded prod by Qualgen, LLC. Reason: Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label..
Details
Source
Drug Recall
External ID
D-0517-2025
Action Date
2025-07-23
Status
Ongoing
Category
drug
Product Description
Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edmond OK 73013, NDC 69761-202-01
Lot/Code Info: Lot number: 1043, Exp. Date 2/10/2026
Quantity Affected: 2,832 amber vials
Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Distribution
Nationwide within the United States.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-16
Company
Edmond, OK
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 51 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (Qualgen, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Qualgen, LLC have FDA actions?
This is the only FDA action we have on record for Qualgen, LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0517-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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