FDA Drug recall D-0387-2016
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 (ND…
- FDA Drug
- Class II
- terminated
- Published 2015-12-02
On 2015-12-02 the FDA classified a Class II recall of 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 (ND… by Qualgen, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0387-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-09 |
| Published | 2015-12-02 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Qualgen |
| Distribution | US |
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
Reason
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.
Identifiers
| 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; A01…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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0387-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.