The Recall Desk
LowFDA (Drugs)·D-0911-2017·Announced 2017-06-21

Pharmedium Recalls Potassium Phosphate IV Bags Due to Incorrect Volume Labeling

Pharmedium Services, LLC is recalling 672 bags of Potassium Phosphate IV solution because the printed volume on the label is incorrect.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The hazard is a minor labeling error regarding volume, with no reported injuries.

Plain-English summary

Pharmedium Services, LLC is recalling 672 bags of Potassium PHOSphate added to 0.9% Sodium Chloride, 10 mMol 100 mL Bag. The product is identified by NDC# 61553-0288-48 and Service Code 2K5288. The recall is due to a labeling error where the total volume is incorrectly printed as 103.33 mL instead of the actual 100.00 mL.

The affected product is prescription-only (Rx Only) and was distributed nationwide in the USA. The recall covers specific lot numbers with expiration dates ranging from March 30, 2017, to May 11, 2017. The source text does not report any illnesses or injuries associated with this labeling error.

Healthcare providers and patients should verify the volume on the product label against the actual contents before administration. If the label indicates 103.33 mL, the product should not be used and should be returned to the supplier or disposed of according to local regulations.

The recalled product

Product
Potassium PHOSphate added to 0.9% Sodium Chloride, 10 mMol 100 mL Bag, Service Code 2K5288, NDC# 61553-0288-48, Total Volume 100.00 mL incorrectly labeled as 103.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Affected units
672

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)

  • Lot Numbers: 163640076D
  • 3/30/2017
  • 170040009D
  • 4/5/2017
  • 170040224S
  • 170040065S
  • 170050068D
  • 4/6/2017
  • 170060353S
  • 4/9/2017
  • 170100076D
  • 4/11/2017
  • 170100111S
  • 170120090D
  • 4/13/2017
  • 170120154S
  • 170160150S
  • 4/17/2017
  • 170260005D
  • 4/27/2017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by Pharmedium Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →