FDA Drug Class II — Moderate

Testosterone Cypionate in Sesame Oil Injectable 200 mg/mL, a) 1 mL and b) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL

Hazard

Lack of Assurance of Sterility

Products

Testosterone Cypionate in Sesame Oil Injectable 200 mg/mL, a) 1 mL and b) 10 mL vials, 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. a) Known lot code: 03202016@10, 04072016@85, 04182016@4, 05062016@5, 05262016@1, 06132016@1, 08112016@4 b) Known lot code: 03282016@6, 04122016@2, 04182016@33, 05092016@6, 05192016@3, 06022016@5, 06072016@3, 06172016@3, 06292016@2, 07112016@5, 07262016@29, 07292016@12.

Units Affected

a) 798 vials and b) 3,191 vials