Drug product
Chorionic Gonadotropin, Lyophilized, 5,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
D-0348-2017
Product summary
- Event
- Event 75289
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5277 kits (number of vials per kit vary by prescription)
- Official record key
drug-enforcement:D-0348-2017
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 kit lot code: 04142016@75, 04252016@52, 05042016@143, 05042016@158, 06092016@169, 06242016@158, 08022016@154, 08112016@56, 08252016@82, 09082016@41. Known vial lot code: 04062016@7, 04182016@49, 04292016@80, 04282016@43, 06012016@44, 06152016@57, 07132016@68, 08042016@35, 08192016@45, 08242016@33
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility