FDA Drug Class II — Moderate

Tri 1 (PAP/PHEN/ATROPINE) NR Injectable, 3.6 mg/0.4 mg/0.04 mg/mL, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL

Hazard

Lack of Assurance of Sterility

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Products

Tri 1 (PAP/PHEN/ATROPINE) NR Injectable, 3.6 mg/0.4 mg/0.04 mg/mL, a) 2 mL and b) 5 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: 04072016@10, 05102016@18, 06232016@12, 08182016@26 b) Known lot code: 04122016@19, 05042016@18, 06142016@43, 07122016@40, 07262016@47.

Units Affected

a) 257 vials and b) 460 vials

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