D-0385-2017 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
114 vials and b) 1,017 vials

Product Description

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

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: 04072016@8, 06272016@22, 09082016@29 b) Known lot code: 04142016@16, 04272016@8, 06102016@13, 07062016@29, 08052016@1.