Class II · Moderate risk
Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Hipoglos Ointment
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Misbranded
Cause type: Unapproved drug
The product was marketed without an approved NDA/ANDA, or does not meet the OTC monograph it claims to follow. Nothing about the product - dose, purity, safety - has been reviewed by FDA, so the claims on the box are unverified. All unapproved drug recalls.
What was recalled
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.
Affected NDCs
50145-0111-01
50145-0111-02
50145-0111-03
50145-0111-04
50145-0111-05
Compare with the code on your package — it is the most precise check available.
Drug: Zinc
- Recalling firm
- Victus, Inc.
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1652-2012 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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Class II · Moderate risk
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CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
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CGMP Deviations; deficiencies observed during FDA inspection
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