Drug product
Chorionic Gonadotropin, Lyophilized, 3,500 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
D-0347-2017
Product summary
- Event
- Event 75289
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1753 kits (number of vials per kit vary)
- Official record key
drug-enforcement:D-0347-2017
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: 04212016@46, 05232016@215, 05232016@216, 07052016@89, 08042016@103, 09132016@116. Known vial lot code: 04132016@91, 05162016@136, 06242016@96, 07282016@51, 09092016@20
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility