FDA Drug Class II — Moderate

Trimix Injectable 30 mg/1 mg/10 mcg/mL a) 2 mL and b) 5 mL and c) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL

Hazard

Lack of Assurance of Sterility

Products

Trimix Injectable 30 mg/1 mg/10 mcg/mL a) 2 mL and b) 5 mL and c) 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: 07222016@15 b) Known lot code: 04122016@17, 05182016@16, 09082016@28 c) Known lot code: 04072016@13, 05192016@22, 06132016@36, 08032016@35.

Units Affected

a) 9 vials and b) 78 vials, c) 210 vials