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FDAFDA · Food and drugs·Recall number D-0407-2017

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

Published January 11, 2017 · Recall initiated: September 21, 2016

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Lack of Assurance of Sterility

What to do

Voluntary: Firm initiated · Press Release

Recall details

Manufacturer
Wells Pharmacy Network LLC
Distributor
Nationwide
Lot
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.
Risk classification
Class II
Area (FDA)
drug
Country
United States

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