FDA Drug Class II — Moderate

Sermorelin Acetate 9 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

Hazard

Lack of Assurance of Sterility

Products

Sermorelin Acetate 9 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: 04212016@55, 06222016@106. Known vial lot code: 04142016@31, 06012016@50.

Units Affected

629 kits (number of vials per kit vary by prescription)