Enforcement Report - Week of August 29, 2012
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Product Detail
| 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. |
|---|---|
| Recall Number | D-1652-2012 |
| Classification | Class II |
| Code Info | 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 |
| Product Distributed Qty | 1,535 Tubes |
| Reason For Recall | Misbranded |
Event Detail
| Event Id | 62541 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Victus, Inc. |
| City | Miami |
| State | FL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2011-11-10 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Distribution Pattern | FL |
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