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Recall Observatory FDA recall evidence

Drug product

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

D-0517-2025

June 16, 2025

Class III

Product summary

Firm
Qualgen, LLC
Event
Event 97086
Status
Ongoing
Classification
Class III
Quantity
2,832 amber vials
Official record key
drug-enforcement:D-0517-2025

Official wording

Reason: Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.

Code information: Lot number: 1043, Exp. Date 2/10/2026

Distribution pattern: Nationwide within the United States.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing