Recalls / Class II
Class IID-0387-2016
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, Oklahoma 73013
- Affected lot / code info
- 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
Why it was recalled
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.
Recalling firm
- Firm
- Qualgen
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 14844 Bristol Park Blvd, N/A, Edmond, Oklahoma 73013-1891
Distribution
- Quantity
- 10,885 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-10-09
- FDA classified
- 2015-11-24
- Posted by FDA
- 2015-12-02
- Terminated
- 2017-03-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0387-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.