Hipoglos Ointment (zinc oxide and lanolin), Helps prevent and treat diaper rash, skin irritation,...
FDA Recall #D-1652-2012 — Class II — November 10, 2011
Product Description
Hipoglos Ointment (zinc oxide and lanolin), Helps prevent and treat diaper rash, skin irritation, Manufactured by Laboratorios Andromaco S.A. Av. Quilin 5273, Penalolen, Santiago. www.hipoglos.cl, www.laboratoriosandromaco.cl, Made in Chile, Net wt. per Tube: a) 0.18 oz (5 g), NDC: 50145-111-05; b) 2.2 oz (60 g), NDC: 50145-111-04; c) 2.5 oz (72 g), NDC: 50145-111-03; d) 3.5 oz (100 g), NDC: 50145-111-02; e) 4.2 oz (120 g), NDC: 50145-111-01.
Reason for Recall
Misbranded
Recalling Firm
Victus, Inc. — Miami, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1,535 Tubes
Distribution
FL
Code Information
Lot #/Product #: a) C1557B/MM26306, Exp 03/31/2014; b) C1387B/PV16856, Exp 03/31/2014, G0288C/PV16856, Exp 07/31/2013; c) G0288A/PV16855, Exp 07/31/2013; d) G0289B/PV16854, Exp 07/31/2013; e) C1387A/PV16853, Exp 03/31/2014, G0288B/PV16853, Exp 07/31/2013
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated