Drug product
Sermorelin Acetate/GHRP (2) & (6) 9 mg/9 mg/9 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
D-0390-2017
Product summary
- Event
- Event 75289
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,319 kits (number of vials per kit vary by prescription)
- Official record key
drug-enforcement:D-0390-2017
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: 04072016@19, 05272016@55, 06102016@62, 09062016@75. Known vial lot code: 03302016@11, 050412016@98, 05172016@10, 08252016@18.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility