FDA recall D-1652-2012

Victus, Inc. · Class II · drug

Product

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

Distribution

Key facts

Status: Terminated
Initiation date: 2011-11-10
Report date: 2012-08-29
Termination date: 2013-07-25
Voluntary/Mandated: Voluntary: Firm initiated
Location: Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1652-2012