Drug product
Testosterone Cypionate in Sesame Oil Injectable 200 mg/mL, a) 1 mL and b) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL
D-0402-2017
Product summary
- Event
- Event 75289
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 798 vials and b) 3,191 vials
- Official record key
drug-enforcement:D-0402-2017
Official wording
Reason: Lack of Assurance of Sterility
Code information: All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 03202016@10, 04072016@85, 04182016@4, 05062016@5, 05262016@1, 06132016@1, 08112016@4 b) Known lot code: 03282016@6, 04122016@2, 04182016@33, 05092016@6, 05192016@3, 06022016@5, 06072016@3, 06172016@3, 06292016@2, 07112016@5, 07262016@29, 07292016@12.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility