Class II · Moderate risk
Metronidazole 500mg 100ml
Lack of sterility assurance
Metronidazole 500mg Tablet
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
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
Metronidazole 500mg Tablet, 50-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 5011133402
Affected NDC
50111-3340-02
Compare with the code on your package — it is the most precise check available.
Drug: Metronidazole Category: Antibiotic
- Recalling firm
- Safecor Health, LLC
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0905-2017 · 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.
Other Metronidazole recalls
See all
Class II · Moderate risk
Metronidazole tablets
cGMP deviations: Temperature abuse
Class II · Moderate risk
Metronidazole Vaginal Gel USP
cGMP deviations: Temperature abuse
Class II · Moderate risk
Metronidazole Injection
Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
Class II · Moderate risk
Metronidazole 1% Gel
Lack of Assurance of Sterility: There are also CGMP Deviations.
Other recalls by Safecor Health, LLC
All 2016 recalls
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
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