Recalls / Class II
Class IID-0395-2017
Product
Sermorelin Acetate/GHRP (2) 9 mg/3 mg 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: 04152016@149, 05182016@176, 06172016@142, 07272016@83, 08232016@32, 09122016@138. Known vial lot code: 04072016@91, 04262016@27, 05272016@41, 07192016@29, 08192016@18, 09062016@44.
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
- 2,264 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-0395-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.