Class II · Moderate risk Terminated
Metronidazole 500mg 100ml
Reason Lack of sterility assurance
Metronidazole Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications.
What was recalled
Metronidazole Tablets, USP, 500 mg, packaged in a) 10-count tablets per bottle (NDC 54868-0158-3); b) 14-count tablets per bottle (NDC 54868-0158-1); c) 20-count tablets per bottle (NDC 54868-0158-5); d) 21-count tablets per bottle (NDC 54868-0158-0); e) 30-count tablets per bottle (NDC 54868-0158-8), Rx only, Mfg. By: Pliva Krakow Pharma. Comp., Krakow, Poland; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146.
- Recalling firm
- Physicians Total Care, Inc.
- NDC code
- 54868-0158-3
- Origin
- OK, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-547-2013
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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