FDA Drug Class II — Moderate

QUAD4 (PAP/PHEN/ALPROS/ATRO) 30 mg/3 mg/60 mcg/0.2 mg/mL Injectable, 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

QUAD4 (PAP/PHEN/ALPROS/ATRO) 30 mg/3 mg/60 mcg/0.2 mg/mL Injectable, 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@8, 06272016@22, 09082016@29 b) Known lot code: 04142016@16, 04272016@8, 06102016@13, 07062016@29, 08052016@1.

Units Affected

114 vials and b) 1,017 vials

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