April 2011 FDA Recall Drug by Physicians Total Care, Inc.
D-547-2013 - Failed Tablet/Capsule Specifications

This Class II drug recall was voluntarily initiated by Physicians Total Care, Inc. on April 6, 2011 for the product Drug. The FDA reported the reason for recall as failed tablet/capsule specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-547-2013

Reason for Recall
Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications.
Initiated
04-06-2011
Reported
06-12-2013
Quantity
25230 tablets: a) 190 bottles, b) 743 bottles, c) 293 bottles, d) 8 bottles, e) 230 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65269
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Physicians Total Care, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-29-2013
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 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.