Recalls / Class II
Class IID-0231-2019
Product
Testosterone 100mg pellet, 1 count (NDC 69761-110-01), 6 count (NDC 69761-110-06), 12 count (NDC 69761-110-12), and 30 count (NDC 69761-110-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
- Affected lot / code info
- Lots: C232 BUD: 11/3/2018; C239 BUD: 11/14/2018; C246 BUD: 11/29/2018; C260 BUD: 12/19/2018; D004 BUD: 1/4/2019; D017 BUD: 1/18/2019; D023 BUD: 1/26/2019; D053 BUD: 3/6/2019
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Qualgen, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 14844 Bristol Park Blvd, Edmond, Oklahoma 73013-1891
Distribution
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2018-10-17
- FDA classified
- 2018-11-07
- Posted by FDA
- 2018-11-14
- Terminated
- 2020-06-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0231-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.