Recalls / Class II
Class IID-0336-2017
Product
Chorionic Gonadotropin, Lyophilized (HCG) 11,000 Unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
- Affected lot / code info
- 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.
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Wells Pharmacy Network LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1210 SW 33rd Ave, N/A, Ocala, Florida 34474-2853
Distribution
- Quantity
- 10 kits
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-09-21
- FDA classified
- 2017-01-04
- Posted by FDA
- 2017-01-11
- Terminated
- 2021-07-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0336-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.