D-1652-2012 Class II Terminated
FDA drug recall D-1652-2012 was initiated by Victus, Inc. on November 10, 2011 and is designated Class II. Reason for recall: Misbranded The recall status is terminated (terminated July 25, 2013). Affected quantity: 1,535 Tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- August 29, 2012
- Initiation Date
- November 10, 2011
- Termination Date
- July 25, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,535 Tubes
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
Distribution Pattern
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