FDA Drug Class II — Moderate

Sermorelin Acetate/GHRP (2) & (6) 9 mg/3.15 mg/3.15 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

Hazard

Lack of Assurance of Sterility

Products

Sermorelin Acetate/GHRP (2) & (6) 9 mg/3.15 mg/3.15 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
Brand
Wells Pharmacy Network LLC
UPC
All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 05122016@180, 06132016@155, 06232016@147, 07062016@156, 07272016@68, 08232016@24, 09062016@74. Known vial lot code: 04212016@110, 052412016@76, 05312016@40, 06102016@52, 07152016@56, 08192016@20, 08102016@56.

Units Affected

3,089 kits (number of vials per kit vary by prescription)