Class II · Moderate risk
Auryxia (ferric citrate)
CGMP Deviations
Sunstar GUM Toothpaste 3 g tubes
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviation
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
Sunstar GUM Toothpaste 3 g tubes, Toothpaste made in Japan, packed in China, NDC 53050-0002-01
Affected NDC
53050-0002-01
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Sunstar Guangzhou Ltd.
- NDC code
- 53050-0002-01
- Origin
- China
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0997-2020 · 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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All cgmp deviation recalls
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CGMP Deviations
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