PlainRecalls
FDA Drug Moderate Class II Terminated

Testosterone 12.5mg pellet, 1 count (NDC 69761-112-01), 6 count (NDC 69761-112-06), 12 count (NDC 69761-112-12), and 30 count (NDC 69761-112-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013

Reported: November 14, 2018 Initiated: October 17, 2018 #D-0232-2019

Product Description

Testosterone 12.5mg pellet, 1 count (NDC 69761-112-01), 6 count (NDC 69761-112-06), 12 count (NDC 69761-112-12), and 30 count (NDC 69761-112-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013

Reason for Recall

Lack of Assurance of Sterility

Details

Recalling Firm
Qualgen, LLC
Distribution
Nationwide.
Location
Edmond, OK

Frequently Asked Questions

What product was recalled?
Testosterone 12.5mg pellet, 1 count (NDC 69761-112-01), 6 count (NDC 69761-112-06), 12 count (NDC 69761-112-12), and 30 count (NDC 69761-112-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013. Recalled by Qualgen, LLC.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on November 14, 2018. Severity: Moderate. Recall number: D-0232-2019.