Drug product
Chorionic Gonadotropin (New York State), 11,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
D-0346-2017
Product summary
- Event
- Event 75289
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18 kits (number of vials per kit vary by prescription)
- Official record key
drug-enforcement:D-0346-2017
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: 06072016@44, 07292016@92, 08092016@80, 09132016@33. Known vial lot code: 04042016@30, 07222016@26, 04042016@30, 08252016@3
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility