FDA Drug Class II — Moderate

Testosterone Cypionate in Grapeseed Oil Injectable, 200 mg/mL, a) 1 mL b) 3 mL c) 5 mL and d) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL

Hazard

Lack of Assurance of Sterility

Products

Testosterone Cypionate in Grapeseed Oil Injectable, 200 mg/mL, a) 1 mL b) 3 mL c) 5 mL and d) 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 codes: 03282016@16, 03302016@4, 04042016@10, 04262016@3, 05162016@2, 06032016@2, 07062016@10, 08262016@2 b) Known lot code: 04012016@4, 04182016@6, 04282016@7, 05022016@4, 06142016@19, 08102016@22. c) Known lot code: 04042016@7, 05022016@9, 05272016@2, 06272016@13, 07292016@8, 08192016@10 d) Known lot code: 03242016@12, 04082016@6, 04142016@2, 04192016@5, 04272016@4, 05092016@4, 05232016@17, 06122016@6, 06082016@2, 06142016@148, 06162016@9, 06172016@13, 06232016@78, 06282016@31, 07122016@20, 08012016@25, 08032016@12, 08042016@13.

Units Affected

a) 694 vials b) 389 vials c) 695 vials d) 5193 vials