Drug Enforcement D-547-2013

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

Status

Terminated

Classification

Class II

Report Date

June 12, 2013

Termination Date

July 29, 2013

Product Information

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.
Product quantity
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.
Recall initiation reason
—
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Physicians Total Care, Inc.
Address
12515 E 55th St Ste 100, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-547-2013
Event ID
65269
Recall initiation date
April 6, 2011
Center classification date
June 4, 2013
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.
More code info
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