The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0387-2016·Announced 2015-12-02

Qualgen Recalls Testosterone Pellets Due to Sterility Assurance Concerns

Qualgen is recalling 10,885 vials of compounded Testosterone USP pellets nationwide due to deficient practices that may impact sterility assurance.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (sterile injection) where injury has not yet been reported, fitting the High severity criteria for theoretical hazards without confirmed illness.

Plain-English summary

Qualgen is voluntarily recalling 10,885 vials of Testosterone USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials. The affected products are prescription-only (Rx only) and were compounded by Qualgen in Edmond, Oklahoma. The recall covers multiple strengths, including 25 mg, 37.5 mg, 50 mg, 87.5 mg, 100 mg, and 200 mg, distributed nationwide.

The recall is being conducted due to a lack of assurance of sterility. The firm identified deficient practices that may have an impact on sterility assurance for all sterile preparations within their expiry dates. The source text does not report any specific illnesses or injuries associated with these products.

Patients who have received these specific vials should contact their healthcare provider or pharmacist for guidance on next steps. The recall includes specific lot numbers with expiration dates ranging from October 30, 2015, to December 24, 2015.

The recalled product

Product
Testosterone USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 25 mg (NDC 69761-125-01), 37.5 mg (NDC 69761-137-01), 50 mg (NDC 69761-150-01), 87.5 mg (NDC: 69761-187-01), 100 mg (NDC 69761-110-01), 200 mg (NDC 69761-120-01), Rx only, Compounded by Qualgen, Edmond…
Manufacturer
Qualgen
Category
Drug — Compounded Sterile Preparation
Hazard
Affected units
10,885

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lots: A005 Ex.: 10/30/2015
  • A008 Ex.: 11/01/2015
  • A010 Ex.: 11/06/2015
  • A012 Ex.: 11/07/2015
  • A015 Ex.: 11/08/2015
  • A018 Ex.: 11/13/2015
  • A022 Ex.: 11/14/2015
  • A024 Ex.: 11/16/2015
  • A026 Ex.: 11/20/2015
  • A029 Ex.: 11/21/2015
  • A033 Ex.: 11/23/2015
  • A038 Ex.: 11/24/2015
  • A040 Ex.: 11/27/2015
  • A041 Ex.: 11/28/2015
  • A045 Ex.: 12/03/2015
  • A046 Ex.: 11/30/2015
  • A047 Ex.: 12/04/2015
  • A052 Ex.: 12/12/2015
  • A055 Ex.: 12/13/2015
  • A058 Ex.: 12/18/2015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Qualgen under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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