Status
Ongoing
Drug Enforcement D-0517-2025
Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Classification
Class III
Report Date
July 23, 2025
Termination Date
—
Product Information
- 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
- Product quantity
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide within the United States.
Location & Firm
- Recalling firm
- Qualgen, LLC
- Address
-
14844 Bristol Park Blvd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0517-2025
- Event ID
- 97086
- Recall initiation date
- June 16, 2025
- Center classification date
- July 14, 2025
- Code info
- Lot number: 1043, Exp. Date 2/10/2026
- More code info
- —