Recalls / Class II
Class IID-0327-2017
Product
Testosterone Cypionate in Grapeseed Oil Injectable, 200 mg/mL, a) 1 mL b) 3 mL c) 5 mL and d) 10 mL vials, 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. a) Known lot codes: 03282016@16, 03302016@4, 04042016@10, 04262016@3, 05162016@2, 06032016@2, 07062016@10, 08262016@2 b) Known lot code: 04012016@4, 04182016@6, 04282016@7, 05022016@4, 06142016@19, 08102016@22. c) Known lot code: 04042016@7, 05022016@9, 05272016@2, 06272016@13, 07292016@8, 08192016@10 d) Known lot code: 03242016@12, 04082016@6, 04142016@2, 04192016@5, 04272016@4, 05092016@4, 05232016@17, 06122016@6, 06082016@2, 06142016@148, 06162016@9, 06172016@13, 06232016@78, 06282016@31, 07122016@20, 08012016@25, 08032016@12, 08042016@13.
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
- a) 694 vials b) 389 vials c) 695 vials d) 5193 vials
- 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-0327-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.