Class II · Moderate risk Ongoing
[CORRECT FRONT PANEL] Hydrogen Peroxide Topical Solution
Reason Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol
Hydrogen Peroxide Pf 3% Injectable 150 Ml
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
What was recalled
HYDROGEN PEROXIDE PF 3% INJECTABLE 150 ML, 200 ML, 50 ML, 60 ML (4 DIFFERENT PRODUCTS)
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1539-2012
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Hydrogen recalls
See all
Class II · Moderate risk Ongoing
Hydrogen Peroxide Oral Rinse
Reason CGMP Deviations: products may not conform to the labeled specifications.
Class II · Moderate risk Ongoing
Colgate Anticavity Fluoride Toothpaste
Reason cGMP deviation: Product held outside of appropriate temperature storage conditions.
Class II · Moderate risk Ongoing
Colgate Anticavity Fluoride Toothpaste
Reason cGMP deviation: Product held outside of appropriate temperature storage conditions.
Class II · Moderate risk Terminated
Hydrogen Peroxide Topical Solution USP
Reason Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol.
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