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, Oklahoma 73013

Class I - Dangerous
💊 Drugs Recalled: October 9, 2015 Qualgen Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    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; A059 Ex.: 12/19/2015; A061 Ex.: 12/24/2015
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Qualgen
Reason for Recall:
Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility assurance.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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, Oklahoma 73013

Product Codes/Lot Numbers:

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; A059 Ex.: 12/19/2015; A061 Ex.: 12/24/2015

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0387-2016

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