FDA recall D-0387-2016

Qualgen · Class II · drug

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 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.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2015-10-09
Report date: 2015-12-02
Termination date: 2017-03-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Edmond, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0387-2016