Drug product
Alprostadil 40 mcg/mL Injectable, 10 mL vials, Compounded by Wells Pharmacy Network LLC, Ocala FL
D-0339-2017
Product summary
- Event
- Event 75289
- Status
- Terminated
- Classification
- Class II
- Quantity
- 37 vials
- Official record key
drug-enforcement:D-0339-2017
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: 05092016@3, 07192016@8
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility