D-0234-2019 Class II Terminated
FDA drug recall D-0234-2019 was initiated by Qualgen, LLC on October 17, 2018 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated June 4, 2020).
Recall Details
- Product Type
- Drugs
- Report Date
- November 14, 2018
- Initiation Date
- October 17, 2018
- Termination Date
- June 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC: 69761-125-30), Rx Only Qualgen, LLC, Edmond, OK 73013
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide.
Code Information
Lots: C235 BUD: 11/10/2018; C241 BUD: 11/17/2018; C251 BUD: 12/8/2018; C265 BUD: 12/28/2018; D008 BUD: 1/9/2019; D018 BUD: 1/19/2019; D022 BUD: 1/25/2019; D032 BUD: 2/7/2019; D037 BUD: 2/13/2019; D057 BUD: 3/8/2019; D061 BUD: 3/14/2019; D069 BUD: 3/23/2019