Drug product
Chorionic Gonadotropin, Lyophilized (HCG) 11,000 Unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
D-0336-2017
Product summary
- Event
- Event 75289
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 kits
- Official record key
drug-enforcement:D-0336-2017
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@16, 04072016@26, 04142016@65, 05172016@105, 06062016@137, 06152016@28, 06232016@61, 07272016@56, 08192016@108, 09062016@127 Known vial lot code: 03252016@6, 03312016@1, 04042016@30, 05052016@134, 05092016@57, 06072016@32, 06172016@120, 07222016@26, 07222016@26, 08122016@3, 08252016@3.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility