The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0906-2017·Announced 2017-06-21

Pharmedium Recalls 216 Bags of Potassium Chloride with Incorrect Volume Labeling

Pharmedium Services, LLC is recalling 216 bags of Potassium Chloride in 0.9% Sodium Chloride because the product labels incorrectly state a volume of 115.00 mL instead of the actual 100.00 mL.

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 FDA classified this as a Class III recall, 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 minor labeling error regarding volume.

Plain-English summary

Pharmedium Services, LLC is recalling 216 bags of Potassium Chloride added to 0.9% Sodium Chloride, 30mEq 100 mL Bag. The product is identified by NDC# 61553-0824-48 and Service Code 2K5824. The recall is due to a labeling error where the total volume is incorrectly printed as 115.00 mL on the product label, whereas the actual total volume is 100.00 mL.

The affected lots are 70090135M, 170250101M, 170030011D, 170040078D, 170310012D, and 170400046D. These products were distributed nationwide in the USA. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

Healthcare providers and consumers should check their inventory for these specific lot numbers and stop using the affected bags. The product is prescription-only (Rx Only). No specific instructions for disposal or return are provided in the source text.

The recalled product

Product
Potassium CHLORide added to 0.9% Sodium Chloride, 30mEq 100 mL Bag, Service Code 2K5824, NDC# 61553-0824-48, Total Volume 100.00 mL incorrectly labeled as 115.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141
Manufacturer
Pharmedium Services, LLC
Category
Drug — IV Solution
Hazard
Affected units
216

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 (12)

  • Lot Numbers: 70090135M
  • 2/27/2017
  • 170250101M
  • 3/15/2017
  • 170030011D
  • 4/4/2017
  • 170040078D
  • 4/5/2017
  • 170310012D
  • 5/2/2017
  • 170400046D
  • 5/11/2017

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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