Drug product
Testosterone Cypionate in Grapeseed Oil Injectable, 100 mg/mL, a) 1mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL
D-0400-2017
Product summary
- Event
- Event 75289
- Status
- Terminated
- Classification
- Class II
- Quantity
- a ) 303 vials and b) 413 vials
- Official record key
drug-enforcement:D-0400-2017
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: 04212016@5, 05102016@123, 05232016@21, 07132016@18 b) Known lot code: 04142016@7, 05042016@6, 05252016@2, 06222016@30, 07132016@25, 07282016@5.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility