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.
Recall Number: D-547-2013
Firm: Physicians Total Care, Inc.
Classification: Class II
Status: Terminated
Report Date: 20130612
Initiation Date: 20110406
Termination Date: 20130729
Reason for Recall
Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications.
Product Description
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.