The Recall Desk
ModerateFDA (Drugs)·D-547-2013·Announced 2013-06-12

Physicians Total Care Recalls Metronidazole Tablets for Weight Specification Failures

Physicians Total Care is recalling Metronidazole Tablets, 500 mg, because some tablets may not conform to weight specifications. The recall covers 25,230 tablets distributed nationwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II due to potential non-conformance to weight specifications, which is a quality control issue. No illnesses or injuries are reported, and the hazard is theoretical, fitting the Moderate severity criteria for minor labeling or specification errors.

Plain-English summary

Physicians Total Care, Inc. is recalling Metronidazole Tablets, USP, 500 mg, because some tablets had the potential to not conform to weight specifications. The affected product is packaged in 10-count, 14-count, 20-count, 21-count, and 30-count bottles. The tablets were manufactured by Pliva Krakow Pharma. Comp. in Krakow, Poland, and repacked and distributed by Physicians Total Care, Inc. in Tulsa, Oklahoma.

The recall involves a total of 25,230 tablets across multiple lot numbers and expiration dates ranging from 2011 to 2013. The distribution pattern for these products was nationwide. The FDA has classified this recall as Class II, which indicates a situation in which there is a reasonable probability that the use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have purchased these specific lots of Metronidazole Tablets should stop using them and contact their healthcare provider or pharmacist for guidance. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

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 bott
Manufacturer
Physicians Total Care, Inc.
Category
Drug — Antibiotic
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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
  • Barr Lot #306670. PTC Lot #48GN
  • Exp 05/31/2011
  • Barr Lot #307039. PTC Lot #4A36
  • Barr Lot #307127. PTC Lot#4AA9
  • Barr Lot #307127. PTC Lot #4ASM
  • Barr Lot #307128. PTC Lot #4AWE
  • Barr Lot# 307128. PTC Lot #4AWG
  • Barr Lot#307128. PTC Lot#4AZR
  • Barr Lot #307128. PTC Lot #4B72

Distribution

Distributed nationwide across the United States.

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