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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Product Detail

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.
Recall Number D-547-2013
Classification Class II
Code Info 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 #307954. PTC Lot #4F8Y; Exp 08/31/2011; Barr Lot #307954. PTC Lot #4F8Z; Exp 08/31/2011; Barr Lot #307954. PTC Lot #4FCP; Exp 08/31/2011; Barr Lot #307954. PTC Lot #4GCM; Exp 08/31/2011; Barr Lot #307954. PTC Lot #4GY4; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4HR8; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4HZ4; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4IE9; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4J14; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4JBR; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4JN3; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4JQ0; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4KFL; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4KT7; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4L2L; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4LWK; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4MAL; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4MEY; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4MX9; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4NBB; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4NBZ; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4O56; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4ORJ; Exp 10/31/2011; Barr Lot #308743. PTC Lot #4PEJ; Exp 10/31/2011; Barr Lot #308743. PTC Lot #4PL1; Exp 10/31/2011; Barr Lot #308743. PTC Lot #4QQF; Exp 10/31/2011; Barr Lot #308743. PTC Lot #4R6O; Exp 11/30/2011; Barr Lot #309609. PTC Lot #4RSK; Exp 11/30/2011; Barr Lot #309609. PTC Lot #4S1U; Exp 11/30/2011; Barr Lot #309609. PTC Lot #4SFI; Exp 11/30/2011; Barr Lot #309609. PTC Lot #4SRT; Exp 11/30/2011; Barr Lot #309609. PTC Lot #4TB2; Exp 11/30/2011; Barr Lot #309609. PTC Lot #4U8D; Exp 11/30/2011; Barr Lot #310817. PTC Lot #4V2G; Exp 11/30/2011; Barr Lot #310817. PTC Lot #4VJG; Exp 11/30/2011; Barr Lot #310817. PTC Lot #4X6N; Exp 12/31/2011; Barr Lot #311069. PTC Lot #4Y9Q; Exp 12/31/2011; Barr Lot #311069. PTC Lot #4XVB; Exp 12/31/2011; Barr Lot #311074. PTC Lot #4XZH; Exp 12/31/2011; Barr Lot #311074. PTC Lot #4Y9P; Exp 12/31/2011; Barr Lot #311074. PTC Lot #5031; Exp 12/31/2011; Barr Lot #311074. PTC Lot #5172; Exp 12/31/2011; Barr Lot #311074. PTC Lot #5698; Exp 12/31/2011; Barr Lot #311074. PTC Lot #56NJ; Exp 12/31/2011; Barr Lot #311074. PTC Lot #56NL; Exp 12/31/2011; Barr Lot #311074. PTC Lot #58XM; Exp 12/31/2011; Barr Lot #311074. PTC Lot #59D2; Exp 12/31/2011; Barr Lot #311074. PTC Lot #4WEJ; Exp 01/31/2012; Barr Lot #311075. PTC Lot #527Z; Exp 12/31/2011; Barr Lot #311145. PTC Lot #52FT; Exp 12/31/2011; Barr Lot #311145. PTC Lot #5328; Exp 12/31/2011; Barr Lot #311145. PTC Lot #53CU; Exp 12/31/2011; Barr Lot #311145. PTC Lot #54AE; Exp 12/31/2011; Barr Lot #311145. PTC Lot #557T; Exp 12/31/2011; Barr Lot #311145. PTC Lot #55QA; Exp 02/28/2012; Barr Lot #311365. PTC Lot #563R; Exp 02/28/2012; Barr Lot #311365. PTC Lot #57WL; Exp 02/28/2012; Barr Lot #311443. PTC Lot #5ASQ; Exp 02/28/2012; Barr Lot #311443. PTC Lot #5BTD; Exp 02/28/2012; Barr Lot #311443. PTC Lot #5BZ9; Exp 02/28/2012; Barr Lot #311443. PTC Lot #5CCB; Exp 02/28/2012; Barr Lot #311443. PTC Lot #5CO2; Exp 02/28/2012; Barr Lot #311443. PTC Lot #5DXG; Exp 02/28/2012; Barr Lot #311443. PTC Lot #5F86; Exp 02/28/2012; Barr Lot #311443. PTC Lot #5KE5; Exp 07/31/2012; Barr Lot #313415. PTC Lot #5KJS; Exp 07/31/2012; Barr Lot #313415. PTC Lot #5KSX; Exp 07/31/2012; Barr Lot #313415. PTC Lot #5DIO; Exp 08/31/2012; Barr Lot #313418. PTC Lot #5DUW; Exp 08/31/2012; Barr Lot #313418. PTC Lot #5H9T; Exp 08/31/2012; Barr Lot #313418. PTC Lot #5HZ3; Exp 08/31/2012; Barr Lot #313418. PTC Lot #5I1B; Exp 08/31/2012; Barr Lot #313418. PTC Lot #5IJ2; Exp 08/31/2012; Barr Lot #313418. PTC Lot #5J2T; Exp 11/30/2012; Barr Lot #314312. PTC Lot #5LPO; Exp 11/30/2012; Barr Lot #314312. PTC Lot #5ME4; Exp 11/30/2012; Barr Lot #314312. PTC Lot #5MNG; Exp 11/30/2012; Barr Lot #314312. PTC Lot #5N7Q; Exp 11/30/2012; Barr Lot #314312. PTC Lot #5OC6; Exp 11/30/2012; Barr Lot #314312. PTC Lot #5PRW; Exp 12/31/2012; Barr Lot #314702. PTC Lot #5QOH; Exp 12/31/2012; Barr Lot #314702. PTC Lot #5QOI; Exp 12/31/2012; Barr Lot #314702. PTC Lot #5RGR; Exp 12/31/2012; Barr Lot #314702. PTC Lot #5RGT; Exp 12/31/2012; Barr Lot #314702. PTC Lot #5OLD; Exp 01/31/2013; Barr Lot #315019. PTC Lot #5TWL; Exp 01/31/2013; Barr Lot #315021. PTC Lot #5SXH; Exp 12/31/2012; Barr Lot #315023. PTC Lot #5T2J; Exp 12/31/2012; Barr Lot #315023. PTC Lot #5TWK; Exp 01/31/2013; Barr Lot #315181. PTC Lot #5U96; Exp 01/31/2013; Barr Lot #315181. PTC Lot #5VDI; Exp 01/31/2013; Barr Lot #315677. PTC Lot #5VNI; Exp 01/31/2013; Barr Lot #315677. PTC Lot #5W14; Exp 01/31/2013; Barr Lot #315677. PTC Lot #5W9R; Exp 01/31/2013; Barr Lot #315677. PTC Lot #5WNV; Exp 01/31/2013; Barr Lot #315678. PTC Lot #5WOC; Exp 01/31/2013; Barr Lot #315678. PTC Lot #5WOD; Exp 01/31/2013; Barr Lot #315678. PTC Lot #5WOE; Exp 01/31/2013; Barr Lot #315678. PTC Lot #5UHJ; Exp 02/28/2013; Barr Lot #315679. PTC Lot #5UUI; Exp 02/28/2013; Barr Lot #315679. PTC Lot #5ZKM; Exp 02/28/2013; Barr Lot #315836. PTC Lot #5ZKN; Exp 02/28/2013; Barr Lot #315836. PTC Lot #60CN; Exp 02/28/2013; Barr Lot #315836. PTC Lot #68C8; Exp 02/28/2013; Barr Lot #316205. PTC Lot #68U6; Exp 02/28/2013; Barr Lot #316205. PTC Lot #68UH; Exp 02/28/2013; Barr Lot #316205. PTC Lot #69QO; Exp 02/28/2013; Barr Lot #316205. PTC Lot #60NB; Exp 11/30/2012; Barr Lot #316241. PTC Lot #60UT; Exp 11/30/2012; Barr Lot #316241. PTC Lot #60UU; Exp 11/30/2012; Barr Lot #316241. PTC Lot #615Y; Exp 11/30/2012; Barr Lot #316241. PTC Lot #6168; Exp 11/30/2012; Barr Lot #316241. PTC Lot #61KO; Exp 11/30/2012; Barr Lot #316241. PTC Lot #61KP; Exp 11/30/2012; Barr Lot #316241. PTC Lot #61RM; Exp 11/30/2012; Barr Lot #316241. PTC Lot #62CO; Exp 03/31/2013; Barr Lot #316298. PTC Lot #63CZ; Exp 03/31/2013; Barr Lot #316298. PTC Lot #63M7; Exp 03/31/2013; Barr Lot #316298. PTC Lot #64AW; Exp 03/31/2013; Barr Lot #316298. PTC Lot #64VH; Exp 03/31/2013; Barr Lot #316450. PTC Lot #6513; Exp 03/31/2013; Barr Lot #316450. PTC Lot #62HE; Exp 03/31/2013; Barr Lot #316622. PTC Lot #66KC; Exp 03/31/2013; Barr Lot #316626. PTC Lot #66KD; Exp 03/31/2013; Barr Lot #316626. PTC Lot #66MC; Exp 03/31/2013; Barr Lot #316626. PTC Lot #683O; Exp 03/31/2013; Barr Lot #316772. PTC Lot #6G1B; Exp 04/30/2013; Barr Lot #317017. PTC Lot #6G1C; Exp 04/30/2013; Barr Lot #317017. PTC Lot #69GY; Exp 03/31/2013; Barr Lot #317018. PTC Lot #69GZ; Exp 03/31/2013; Barr Lot #317018. PTC Lot #69H0; Exp 03/31/2013; Barr Lot #317018. PTC Lot #6G2G; Exp 05/31/2013; Barr Lot #317477. PTC Lot #6GOH; Exp 05/31/2013; Barr Lot #317479. PTC Lot # 494L; Exp 04/30/2011; Barr Lot #701252. PTC Lot #49K7; Exp 04/30/2011; Barr Lot #701252.
Product Distributed Qty 25230 tablets: a) 190 bottles, b) 743 bottles, c) 293 bottles, d) 8 bottles, e) 230 bottles
Reason For Recall Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications.

Event Detail

Event Id 65269
Product Type Drugs
Status Completed
Recalling Firm Physicians Total Care, Inc.
City Tulsa
State OK
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-04-06
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide
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