D-0408-2017 Class II Terminated

Recalled by Wells Pharmacy Network LLC — Ocala, FL

Recall Details

Product Type
Drugs
Report Date
January 11, 2017
Initiation Date
September 21, 2016
Termination Date
July 2, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
a) 238 vials and b) 607 vials

Product Description

Tri 2 (PAP/PHEN/ATROPINE) NR Injectable, 30 mg/3 mg/0.3 mg/mL, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide

Code Information

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 05042016@19, 06142016@28, 07262016@34, 09072016@22 b) Known lot code: 04112016@8, 05232016@2, 06212016@21, 07012016@22, 09082016@31.