Drug product
Testosterone Enanthate in Sesame Oil, 200 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
D-0305-2017
Product summary
- Event
- Event 75763
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,567 vials
- Official record key
drug-enforcement:D-0305-2017
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): 05232016C (11/19/2016), 08122016A (02/28/2017), 11012016J (04/30/2017), 07132016G (01/09/2017), 09012016B (02/28/2017), 09272016A (03/26/2017).
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility