The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0908-2017·Announced 2017-06-21

Pharmedium Recalls Potassium Phosphate Bags With Incorrect Volume Labeling

Pharmedium Services, LLC is recalling 144 bags of Potassium Phosphate in 0.5% Dextrose because the product label incorrectly states a volume of 150 mL instead of the actual 100 mL.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 2/5 (Moderate).

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 a labeling error (incorrect volume) that could lead to dosing errors, but no illnesses or injuries have been reported, fitting the 'Moderate' criteria for minor labeling errors or low-risk issues.

Plain-English summary

Pharmedium Services, LLC is voluntarily recalling 144 bags of Potassium PHOSphate in 0.5% Dextrose, 7.5 mMol in 100 mL (NDC# 61553-0299-48). The recall is due to a labeling error where the product label incorrectly lists the total volume as 150.00 mL, while the actual volume is 100.00 mL. The affected product is prescription-only and was distributed nationwide in the USA.

The affected lots are 170020074D (dated 4/3/2017), 170050071D (dated 4/6/2017), and 170270036D (dated 4/30/2017). The FDA has classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and patients should check their inventory for these specific lot numbers and NDC codes. If found, the product should be quarantined and returned to Pharmedium Services, LLC or the distributor. No illnesses or injuries have been reported in connection with this labeling error.

The recalled product

Product
Potassium PHOSphate in 0.5% Dextrose, 7.5 mMol in 100 mL, Service Code 2K5299, NDC# 61553-0299-48, Total Volume 100.00 mL incorrectly labeled as 150.00 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
144

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 (6)

  • Lot Numbers: 170020074D
  • 4/3/2017
  • 170050071D
  • 4/6/2017
  • 170270036D
  • 4/30/2017

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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