Drug product
ULTRA-TEST (CYP 80%/PROP 20%) Injectable, 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
D-0335-2017
Product summary
- Event
- Event 75289
- Status
- Terminated
- Classification
- Class II
- Quantity
- 325 vials
- Official record key
drug-enforcement:D-0335-2017
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: 04152016@2, 05052016@2, 05192016@7, 07142016@28, 09122016@23
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility