Status
Terminated
Drug Enforcement D-1652-2012
Misbranded
Classification
Class II
Report Date
August 29, 2012
Termination Date
July 25, 2013
Product Information
- 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.
- Product quantity
- 1,535 Tubes
- Reason for recall
- Misbranded
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- FL
Location & Firm
- Recalling firm
- Victus, Inc.
- Address
-
4918 SW 74th Ct, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1652-2012
- Event ID
- 62541
- Recall initiation date
- November 10, 2011
- Center classification date
- August 17, 2012
- 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
- More code info
- —