The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0910-2017·Announced 2017-06-21

Pharmedium Recalls IV Bags With Incorrect Volume Labeling

Pharmedium Services, LLC is recalling 912 bags of Potassium Phosphate IV solution because the printed volume on the label is incorrect.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a labeling error regarding volume.

Plain-English summary

Pharmedium Services, LLC is voluntarily recalling 912 bags of Potassium PHOSphate added to 0.9% Sodium Chloride, 15 mMol 100 mL Bag. The product is identified by NDC# 61553-0295-48 and Service Code 2K5295. The recall was initiated because the total volume of 100.00 mL was incorrectly printed as 105.00 mL on the product label.

The affected lots were distributed nationwide in the USA. The specific lot numbers and dates are: 170050001D (4/5/2017), 170040025D (4/5/2017), 170060046D (4/9/2017), 170090062D (4/10/2017), 170110125S (4/12/2017), 170170016S (4/18/2017), 170200120S (4/23/2017), and 170380108S (5/9/2017).

This is a Class III recall, which indicates that the product is not likely to cause adverse health consequences. Healthcare providers and patients should check their inventory for these specific lot numbers and contact the manufacturer for further instructions.

The recalled product

Product
Potassium PHOSphate added to 0.9% Sodium Chloride, 15 mMol 100 mL Bag, Service Code 2K5295, NDC# 61553-0295-48, Total Volume 100.00 mL incorrectly labeled as105.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Manufacturer
Pharmedium Services, LLC
Category
Drug — IV Solution
Hazard
Affected units
912

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 (15)

  • Lot Numbers: 170050001D
  • 4/5/2017
  • 170040025D
  • 170060046D
  • 4/9/2017
  • 170090062D
  • 4/10/2017
  • 170110125S
  • 4/12/2017
  • 170170016S
  • 4/18/2017
  • 170200120S
  • 4/23/2017
  • 170380108S
  • 5/9/2017

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 →

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