FDA Drug recall D-547-2013

Metronidazole Tablets, USP, 500 mg, packaged in a) 10-count tablets per bottle (NDC 54868-0158-3)

FDA Drug
Class II
terminated
Published 2013-06-12

On 2013-06-12 the FDA classified a Class II recall of Metronidazole Tablets, USP, 500 mg, packaged in a) 10-count tablets per bottle (NDC 54868-0158-3) by Physicians Total Care, citing failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-547-2013
Classification	Class II
Status	terminated
Initiated	2011-04-06
Published	2013-06-12
Last updated	2026-09-13 11:51 UTC
Company	Physicians Total Care
Distribution	US

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

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

Identifiers

code_info	Entry Format for Lots is: PTC Lot #; Exp Date; Distributor Bulk Lot #.PTC Lot #614S; Exp 05/31/2013; Teva Lot #1410811… Entry Format for Lots is: PTC Lot #; Exp Date; Distributor Bulk Lot #.PTC Lot #614S; Exp 05/31/2013; Teva Lot #14108110A. PTC Lot #6HFC; Exp 06/30/2013; Teva Lot #14127710A. PTC Lot #615S; Exp 08/31/2013; Teva Lot #14180910A. PTC Lot #4614; Exp 04/30/2011; Barr Lot #306670. PTC Lot #46TQ; Exp 04/30/2011; Barr Lot #306670. PTC Lot #48GN; Exp 05/31/2011; Barr Lot #307039. PTC Lot #4A36; Exp 05/31/2011; Barr Lot #307127. PTC Lot#4AA9; Exp 05/31/2011; Barr Lot #307127. PTC Lot #4ASM; Exp 05/31/2011; Barr Lot #307128. PTC Lot #4AWE; Exp 05/31/2011; Barr Lot# 307128. PTC Lot #4AWG; Exp 05/31/2011; Barr Lot#307128. PTC Lot#4AZR; Exp 05/31/2011; Barr Lot #307128. PTC Lot #4B72; Exp 05/31/2011; Barr Lot #307128. PTC Lot #4C50; Exp 06/30/2011; Barr Lot #307360. PTC Lot# 4BOZ; Exp 06/30/2011; Barr Lot #307537. PTC Lot #4BPO; Exp 06/30/2011; Barr Lot #307537. PTC Lot #4E2R; Exp 07/31/2011; Barr Lot #307901. PTC Lot #4D68; Exp 08/31/2011; Barr Lot #307953. PTC Lot #4ETP; Exp 08/31/2011; Barr Lot #

code_info

Entry Format for Lots is: PTC Lot #; Exp Date; Distributor Bulk Lot #.PTC Lot #614S; Exp 05/31/2013; Teva Lot #1410811…

Entry Format for Lots is: PTC Lot #; Exp Date; Distributor Bulk Lot #.PTC Lot #614S; Exp 05/31/2013; Teva Lot #14108110A. PTC Lot #6HFC; Exp 06/30/2013; Teva Lot #14127710A. PTC Lot #615S; Exp 08/31/2013; Teva Lot #14180910A. PTC Lot #4614; Exp 04/30/2011; Barr Lot #306670. PTC Lot #46TQ; Exp 04/30/2011; Barr Lot #306670. PTC Lot #48GN; Exp 05/31/2011; Barr Lot #307039. PTC Lot #4A36; Exp 05/31/2011; Barr Lot #307127. PTC Lot#4AA9; Exp 05/31/2011; Barr Lot #307127. PTC Lot #4ASM; Exp 05/31/2011; Barr Lot #307128. PTC Lot #4AWE; Exp 05/31/2011; Barr Lot# 307128. PTC Lot #4AWG; Exp 05/31/2011; Barr Lot#307128. PTC Lot#4AZR; Exp 05/31/2011; Barr Lot #307128. PTC Lot #4B72; Exp 05/31/2011; Barr Lot #307128. PTC Lot #4C50; Exp 06/30/2011; Barr Lot #307360. PTC Lot# 4BOZ; Exp 06/30/2011; Barr Lot #307537. PTC Lot #4BPO; Exp 06/30/2011; Barr Lot #307537. PTC Lot #4E2R; Exp 07/31/2011; Barr Lot #307901. PTC Lot #4D68; Exp 08/31/2011; Barr Lot #307953. PTC Lot #4ETP; Exp 08/31/2011; Barr Lot #

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-547-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.