Drug product
Testosterone Cypionate 200 mg/mL, in a) 5mL vials and b)10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1702-10
D-1338-2019
Product summary
- Event
- Event 82941
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 114 vials and b) 566 vials
- Official record key
drug-enforcement:D-1338-2019
Official wording
Reason: Lack of Sterility Assurance.
Code information: Lot #: a) 10242018:70/P, Exp. 08/31/2019; b) 10242018:70/A Exp. 08/31/2019; 02262019:49/A Exp. 11/30/2019
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of Sterility