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.
Product 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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0387-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 9, 2015
- FDA report date
- Dec 2, 2015
- Quantity
- 10,885 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Qualgen
Original FDA data
Every field from FDA enforcement report D-0387-2016, exactly as published.
Show all FDA fields
- City
- Edmond
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 72401
- Address
- 14844 Bristol Park Blvd
- Code information
- 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
- Postal code
- 73013-1891
- Report date
- Dec 2, 2015
- Product type
- Drugs
- Recall number
- D-0387-2016
- Classification
- Class II
- Recalling firm
- Qualgen
- Product quantity
- 10,885 vials
- Termination date
- Mar 30, 2017
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 9, 2015
- Initial firm notification
- Center classification date
- Nov 24, 2015