FDA recall D-547-2013

Physicians Total Care, Inc. · Class II · drug

Product

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.

Reason for recall

Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2011-04-06
Report date: 2013-06-12
Termination date: 2013-07-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Tulsa, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-547-2013