D-0517-2025 Class III Ongoing
FDA drug recall D-0517-2025 was initiated by Qualgen, LLC on June 16, 2025 and is designated Class III. Reason for recall: Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label. The recall status is ongoing. Affected quantity: 2,832 amber vials.
Recall Details
- Product Type
- Drugs
- Report Date
- July 23, 2025
- Initiation Date
- June 16, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,832 amber vials
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
Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Distribution Pattern
Nationwide within the United States.
Code Information
Lot number: 1043, Exp. Date 2/10/2026