Class II · Moderate risk Terminated
Metronidazole 500mg 100ml
Reason Lack of sterility assurance
Metronidazole Injection USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
What was recalled
Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfield, IL 60015, NDC 0338-1055-48
- Recalling firm
- Baxter Healthcare Corp.
- NDC code
- 0338-1055-48
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-629-2013
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 Metronidazole recalls
See all
Class II · Moderate risk Terminated
Metronidazole tablets
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Metronidazole Vaginal Gel USP
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Metronidazole Injection
Reason 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 Terminated
Metronidazole 1% Gel
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
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