Drug product
Testosterone 200mg pellet, 1 count (NDC 69761-120-01), 6 count (NDC 69761-120-06), 12 count (NDC 69761-120-12), and 30 count (NDC 69761-120-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
D-0233-2019
Product summary
- Firm
- Qualgen, LLC
- Event
- Event 81346
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0233-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: C230 BUD: 11/1/2018; C233 BUD: 11/3/2018; C234 BUD: 11/9/2018; C237 BUD: 11/13/2018; C240 BUD: 11/15/2018; C242 BUD: 11/20/2018; C244 BUD: 11/27/2018; C248 BUD: 12/4/2018; C250 BUD: 12/6/2018; C252 BUD: 12/12/2018; C256 BUD: 12/14/2018; C258 BUD: 12/18/2018; C264 BUD: 12/27/2018; D006 BUD: 1/8/2019; D009 BUD: 1/10/2019; D013 BUD: 1/15/2019; D015 BUD: 1/17/2019; D019 BUD: 1/22/2019; D024 BUD: 1/29/2019; D028 BUD: 2/1/2019; D034 BUD: 2/8/2019; D041 BUD: 2/20/2019; D059 BUD: 3/13/2019; D063 BUD: 3/15/2019; D070 BUD: 3/26/2019
Distribution pattern: Nationwide.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility