Recalls / Class II
Class IID-0348-2017
Product
Chorionic Gonadotropin, Lyophilized, 5,000 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: 04142016@75, 04252016@52, 05042016@143, 05042016@158, 06092016@169, 06242016@158, 08022016@154, 08112016@56, 08252016@82, 09082016@41. Known vial lot code: 04062016@7, 04182016@49, 04292016@80, 04282016@43, 06012016@44, 06152016@57, 07132016@68, 08042016@35, 08192016@45, 08242016@33
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
- 5277 kits (number of vials per kit vary by prescription)
- 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-0348-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.