Class II · Moderate risk
Oatmeal Daily Moisturizing Body Lotion
Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
Kissable Diabetics Foot Cream
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: lack of adequate release testing.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Brands International Corp., Newmarket, ON, L3X 2S2. UPC 6 72008 80925 3
- Recalling firm
- Brands International Corporation
- Origin
- Canada
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0205-2025 · 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.
Other recalls by Brands International Corporation
All 2024 recallsOther cgmp deviation recalls from 2024
All cgmp deviation recalls
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Class II · Moderate risk
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Class II · Moderate risk
Henry Schein
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
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