Drug product
Chorionic Gonadotropin, Lyophilized, 7,500 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
D-0350-2017
Product summary
- Event
- Event 75289
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,638 kits (number of vials per kit vary by prescription)
- Official record key
drug-enforcement:D-0350-2017
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:04052016@14, 05162016@126, 06092016@173, 06202016@137, 08042016@97, 09132016@117. Known vial lot code: 03242016@31, 04262016@25, 06032016@44, 06202016@137, 07252016@56, 09092016@17.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility