Drug product
Testosterone Cypionate in Sesame Oil, 250 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
D-0302-2017
Product summary
- Event
- Event 75763
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,244 vials
- Official record key
drug-enforcement:D-0302-2017
Official wording
Reason: Lack of Assurance of Sterility
Code information: Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06272016A (12/24/2016), 08242016A (02/20/2017), 09212016B (03/20/2017), 07252016A (01/21/2017), 08112016B (02/07/2017), 10252016L (02/28/2017).
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility