Reported Dec 2, 2015 · Terminated
Testosterone USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 25 mg (NDC 69761-125-01), 37.5 mg (NDC…
Qualgen
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Qualgen · 14844 Bristol Park Blvd · Edmond, OK · 73013-1891
Is this the product you have?
Testosterone USP 99.5%.5% Stearic Acid NF Pellets3 mLone-count vials25 mg (NDC 69761-125-01)37.5 mg (NDC 69761-137-01)50 mg (NDC 69761-150-01)87.5
- mg (NDC69761-187-01), 100 mg (NDC 69761-110-01), 200 mg (NDC 69761-120-01), Rx only, Compounded by Qualgen, Edmond, Oklahoma 73013
- Lot codes and dates
22 of 22 products
Products covered by this recall # Product as published 1 A005 Ex.: 10/30/2015 2 A008 Ex.: 11/01/2015 3 A010 Ex.: 11/06/2015 4 A012 Ex.: 11/07/2015 5 A015 Ex.: 11/08/2015 6 A018 Ex.: 11/13/2015 7 A022 Ex.: 11/14/2015 8 A024 Ex.: 11/16/2015 9 A026 Ex.: 11/20/2015 10 A029 Ex.: 11/21/2015 11 A033 Ex.: 11/23/2015 12 A038 Ex.: 11/24/2015 13 A040 Ex.: 11/27/2015 14 A041 Ex.: 11/28/2015 15 A045 Ex.: 12/03/2015 16 A046 Ex.: 11/30/2015 17 A047 Ex.: 12/04/2015 18 A052 Ex.: 12/12/2015 19 A055 Ex.: 12/13/2015 20 A058 Ex.: 12/18/2015 - Amount recalled
- 10,885 vials
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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