Drug product
Nandrolone Decanote (H), 200 mg/mL Injectable, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
D-0382-2017
Product summary
- Event
- Event 75289
- Status
- Terminated
- Classification
- Class II
- Quantity
- 526 vials
- Official record key
drug-enforcement:D-0382-2017
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. Known lot code: 04112016@16, 04282016@3, 05202016@6, 06132016@4, 07052016@1, 07272016@7.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility