Metronidazole Tablets, USP, 500 mg, packaged in a) 10-count tablets per bottle (NDC 54868-0158-3)...
FDA Drug Recall #D-547-2013 - Class II, April 6, 2011
Recall Summary
| Recall Number | D-547-2013 |
| Classification | Class II - Moderate risk |
| Date Initiated | April 6, 2011 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Physicians Total Care, Inc. |
| Location | Tulsa, OK |
| Product Type | Drugs |
| Quantity | 25230 tablets: a) 190 bottles, b) 743 bottles, c) 293 bottles, d) 8 bottles, e) 230 bottles |
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.
Reason for Recall
Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications.
Distribution Pattern
Nationwide
Lot / Code Information
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.
Other Recalls from Physicians Total Care, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0237-2015 | Class II | CEPHALEXIN MONOHYDRATE CAPSULES,USP, 500 mg, 20... | Sep 22, 2014 |
| D-390-2014 | Class II | Carisoprodol IV ( Carisoprodol Tablets USP) 350... | Nov 22, 2013 |
| D-0239-2015 | Class III | Loratadine 24 HR-OTC,10 mg, 30-count bottle, Ma... | Sep 11, 2013 |
| D-826-2013 | Class II | Belladonna Alkaloids/PB (Belladonna Alkaloids /... | Jun 17, 2013 |
| D-499-2013 | Class III | Camila 0.35 mg Tablets, 6 cards of 28 pills, Di... | Mar 18, 2013 |
Frequently Asked Questions
Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping, abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications, even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications, use a drug take-back program.